Engineering

Amgen

Senior Director Engineering

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Director - Engineering Technical Authority (Drug Substance, Infrastructure, and Single-Use)**

**What you will do**

The Senior Director, Engineering Technical Authority, provides enterprise technical leadership for Amgens Drug Substance engineering network, with additional accountability for Single-Use strategy and selected infrastructure support through the Engineering Technical Lead organization. This is a global role with primary focus on the global Drug Substance network.

This leader is responsible for setting technical directions, deploying engineering capability, and ensuring consistent support across capital projects, lifecycle asset management, and global network initiatives. The role connects long-range technical strategy with project execution and site support, ensuring that engineering decisions are scalable, compliant, and aligned across the network.

The position is also the primary Engineering Technical Authority interface for front-end planning and participates in the front-end planning core team to help shape project strategy, technical approach, and engineering engagement for future investments. A Key element of this role will be to drive the Evolution of the ETA organization to develop new capabilities to address the changing technical landscape and to act as leader and change agent amongst their peers in the ETA and other organizations in Global Engineering as we grow and evolve our team.

**Leadership scope**

This role has leadership responsibility for the engineering organization supporting:

- Drug Substance subject matter experts, project engineering, and network technical support
- Single-Use network leadership, Single-Use system design, and Single-Use support for capital projects in Drug Substance and Drug Product
- Engineering Technical Leads supporting capital projects across the global manufacturing network, serving as technical leads for Drug Substance, infrastructure, and other selected engineering scopes
- Engineering global network coordination and technical alignment

This position has multiple direct reports and provides oversight to a broader engineering organization that includes engineering leaders, subject matter experts, project engineers, and Engineering Technical Leads supporting capital projects and network priorities.

**Key responsibilities:**

The ideal candidate is a senior engineering leader with deep technical credibility in biologics manufacturing, strong capital project experience, and the ability to lead through organizational complexity. This person must be comfortable operating at both strategic and execution levels, influencing senior stakeholders, and building strong technical organizations that support global networks and competing priorities.

**Network leadership**

Provide enterprise technical leadership for Drug Substance systems, Single-Use systems, and assigned infrastructure-related scopes. Lead the organization responsible for delivering technical direction, aligned engineering support, and consistent standards across the global manufacturing network. This includes:

- Setting technical direction and aligning engineering strategies, standards, and practices across projects, sites, and network priorities
- Leading the organization responsible for Drug Substance SMEs, project engineers, network support, Single-Use leadership, Engineering Technical Leads, and global network coordination
- Ensuring effective deployment of engineering resources to support capital projects, lifecycle asset management, and network initiatives
- Driving alignment of technical knowledge, lessons learned, standards, and best practices across the network
- Ensuring the organization provides technical support for troubleshooting, reliability improvement, failure analysis, non-conformance response, and other lifecycle needs requiring engineering expertise

**Shape major projects early**

- Serve as the initial point of contact for ETA in front-end planning and participate in the front-end planning core team.
- Help shape project strategy, scope development, technical options, engineering engagement, and the path to successful project execution.

**Lead engineering support for capital projects and network execution**

- Ensure the organization provides effective technical leadership across planning, design, construction, commissioning, qualification, and start-up.
- Oversee Drug Substance subject matter expertise, project engineering support, Single-Use implementation, and Engineering Technical Lead support for major capital projects across the global network.
- Ensure strong technical stewardship for process systems and aligned execution of engineering standards, technical decisions, and support models across projects and sites.

**Leadership and representation**

- Coach direct reports and help build a strong organization of technical leaders and engineering experts.
- Strengthen technical depth, organizational effectiveness, and succession capability within the ETA organization.
- Partner effectively with site leaders, capital project teams, operations, quality, process development, and senior leadership.
- Representing Amgen with external firms, technical societies, and regulatory bodies as needed.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional individual we seek is a leader with these qualifications

**Basic Qualifications:**

- Doctorate degree in Engineering and 5 years of Engineering industry experience OR
- Masters degree in Engineering and 9 years of Engineering industry experience OR
- Bachelors degree in Engineering and 11 years of Engineering industry experience

AND

In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Bachelors or advanced degree in Chemical Engineering, Mechanical Engineering, or another relevant engineering discipline with life science experience
- Significant experience supporting biologics Drug Substance manufacturing facilities and Drug Substance process systems
- Strong understanding of Drug Substance process engineering, manufacturing unit operations, and lifecycle technical support
- Significant experience leading engineering organizations that support capital project design and execution in regulated manufacturing environments
- Demonstrated enterprise technical leadership across multiple sites, projects, and engineering networks
- Experience leading leaders, developing organizations, and building high-performing technical teams
- Significant experience with Single-Use systems, including strategy, design, implementation, and lifecycle support
- Experience leading project engineering organizations, subject matter expert teams, or matrixed technical resources supporting major capital programs
- Experience supporting engineering activities across global manufacturing networks
- Proven ability to shape technical strategy and engineering engagement during front-end planning and early project development
- Strong understanding of capital project delivery, including planning, design, construction, commissioning, qualification, and start-up
- Strong knowledge of applicable regulations and standards, including cGMP, building codes, and applicable pressure vessel and engineering codes
- Excellent communication and interpersonal skills, with the ability to build strong relationships across all levels of the organization
- Strong executive presence and the ability to influence decisions across senior leadership forums
- Financial acumen to deploy initiatives that add shareholder value
- Proven ability to manage multiple priorities and deliver results in a fast-paced environment
- Ability to represent Amgen with outside firms, technical societies, and regulatory bodies
- Knowledge of industry trends, technology developments, and emerging engineering practices

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

California

Senior Packaging Engineer

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Packaging Engineer**

**What you will do**

Lets do this. Lets change the world. The Packaging Engineering department is a key partner to commercial manufacturing, providing direct technical support to ensure reliable, compliant, and efficient packaging operations. In this role, you will work closely with manufacturing teams on the shop floor to sustain packaging line performance, resolve issues in real time, and drive continuous improvement. The position focuses on lifecycle management of packaging systems within a GMP environment, ensuring consistent product supply and operational excellence across commercial production.

This role is highly hands-on and requires applying engineering, physics, and materials science principles to troubleshoot and resolve packaging and material-related challenges in a fast-paced manufacturing setting. You will also play an important role in mentoring junior engineers and supporting the development of technical capabilities within the team.

**Key Responsibilities:**

- Provide day-to-day technical support to commercial packaging operations, including on-the-floor troubleshooting and issue resolution
- Investigate and resolve deviations, non-conformances, and packaging-related events, including root cause analysis and implementation of effective CAPAs
- Support packaging line performance by identifying and implementing improvements to enhance efficiency, reduce downtime, and minimize waste
- Evaluate and qualify packaging materials to ensure suitability for commercial manufacturing, including managing material changes and supplier issues
- Develop and execute test protocols, generate technical assessments, and support documentation required for material and process changes
- Collaborate closely with Manufacturing, QA, Supply Chain, Maintenance, and Regulatory teams to ensure alignment and rapid issue resolution
- Manage and prioritize multiple operational and project-based activities to meet production schedules and business needs

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The packaging professional we seek will possess these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of Engineering, Materials Science, or Industrial Design experience

OR

Bachelors degree and 4 years of Engineering, Materials Science, or Industrial Design experience

OR

Associates degree and 8 years of Engineering, Materials Science, or Industrial Design experience

OR

High school diploma / GED and 10 years of Engineering, Materials Science, or Industrial Design experience

**Preferred Qualifications:**

- Bachelors or Masters degree in Engineering, Materials Science, or Industrial Design
- Minimum of 5 years of experience in pharmaceutical packaging, with strong exposure to commercial manufacturing support
- Hands-on experience in a GMP manufacturing environment, including deviation management and root cause analysis
- Demonstrated ability to work effectively in a fast-paced, operations-driven setting
- Experience leading or mentoring team members is preferred
- Strong problem-solving, communication, and cross-functional collaboration skills

A strong understanding of materials commonly used in pharmaceutical packaging is essential. Familiarity with the structural and chemical properties of glass, polymers, adhesives, inks, varnishes, and paper is critical to effectively support manufacturing operations.

If you are motivated by solving real-time challenges on the production floor and ensuring consistent, high-quality product supply, this role offers an excellent opportunity to make a direct impact.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Ohio

Device Engineering Sr. Engineer

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Device Engineering Sr. Engineer**

**What you will do**

Lets do this. Lets change the world. In this vital role you will join our Device Engineering group to support device development and engineering robustness. In support of Amgens mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize, and continuously improve drug delivery devices to optimize the patient experience.

The Sr Engineer role is a cross-discipline execution role within the Design for Robustness framework. The role ensures consistent and structured application of robustness methodologies across mechanical design projects, integrating insights from device performance, sources of variation, load cases, materials, assembly, and manufacturing perspectives. While not serving as the formal discipline authority, the role strengthens project robustness execution and supports discipline SMEs under centralized governance.

The Sr Engineer operates across disciplines and may execute within individual Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, depending on project needs and targeted training.

The position is based at our Amgen Massachusetts site with the possibility of a flexible working arrangement meeting business and private needs. You will be joining Amgen device development team consisting of 50+ engineers. This position will report to the Robustness Disciplines Lead.

Responsibilities:

- Independently execute tasks within one or more of the Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM.
- Provide technical recommendations to improve design performance, reduce sensitivity to variation, and enhance overall system robustness
- Collaborate across robustness disciplines to identify risks and mitigations, opportunities and best trade-off solutions.
- Contribute to continuous improvement of robustness disciplines and tools by identifying gaps, proposing improvements, and supporting implementation under governance frameworks.
- Interface effectively with discipline SMEs and incorporating guidance while maintaining ownership of robustness execution within assigned scope
- Drive structured problem-solving and root cause analysis for design, test, and field performance issues, ensuring robust corrective solutions.
- Collaborate closely with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures.
- Apply systems-level thinking to anticipate how design decisions impact downstream manufacturability and performance.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of Engineering experience

OR

Bachelors degree and 4 years of Engineering experience

OR

Associates degree and 8 years Engineering experience

OR

High school diploma / GED and 10 years of Engineering experience

**Preferred Qualifications:**

- 5+ years of progressive experience as a mechanical engineer.
- 3+ years of experience within development of Medical Devices, ideally Class II and Class III.
- Experience in mechanical engineering disciplines and tools, with hands-on work in at least one Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, and preferably exposure to several.
- Strong interpersonal skills
- Ability to work within cross-cultural project teams
- Systematic problem solver and solution developer also when presented with conflicting needs and technical issues.
- Experience in drug/device combination product design and development
- Technical understanding of manufacturing processes (injection molding, assembly processes)
- Technical understanding of drawings and design documentation.
- Understands documentation flow for GMP deliverables
- Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
- Familiar with: US Good Manufacturing Practices - 21CFR820; Quality Management - ISO 13485; Needle-based injection systems for medical use - ISO 11608; Risk Management - ISO 14971.
- Strong communication and presentation skills
- Fluent in English language

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Massachusetts

Engineer I

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Engineer I**

**What you will do**

Lets do this. Lets change the world. In this vital role you will support manufacturing processes in Thousand Oaks Pilot Plant. Responsibilities include providing operational support, troubleshooting, and optimization for assigned equipment; advising and applying engineering principles to the design and implementation of new equipment (Stainless and Single Use Systems).

- Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts, including identifying cycle reduction time opportunities, efficiency gains, and yield improvement opportunities.
- Support technical investigations, root cause analysis, and equipment troubleshooting activities. Apply structured problem-solving methodologies with guidance.
- Analyze data and assist in developing engineering solutions using data techniques and methodologies (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)
- Support new product and technology introductions by assisting with engineering assessments, equipment modifications, and execution of engineering runs.
- Collect, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity
- Provide onsite day-to-day technical support for equipment and process troubleshooting.
- Apply process engineering principles to support the design, specification, installation, startup, and validation of process equipment and systems
- Assists with project activities by performing engineering studies and assessments for process equipment systems
- Translate user and process requirements into engineering documentation and support design development in alignment with standard engineering practices.
- Communicate effectively with supervisors, cross-functional teams, and support staff to escalate issues and contribute to solutions.
- Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a motivated individual with these qualifications.

**Basic Qualifications:**

Masters degree 2 years of Engineering experience

OR

Bachelors degree and 4 years of Engineering experience

OR

Associates degree and 6 years of Engineering experience

OR

High school diploma / GED and 8 years of Engineering experience

**Preferred Qualifications:**

- Bachelors degree in Chemical Engineering, Mechanical Engineering, or Bioengineering preferred
- Direct experience with regulated environments (e.g. FDA, cGMP, OSHA, EPA, etc.) is preferred.
- Subject Matter Expert and hands-on experience with complex manufacturing process equipment including sophisticated troubleshooting, reliability and performance improvements, and design optimization.
- Direct experience in equipment engineering and problem solving for cleaning, centrifuges, chromatography systems, and/or filtration systems.
- Have a foundational knowledge of Maximo or equivalent Asset Management System for managing equipment maintenance and asset lifecycle.
- Solid understanding and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in corrective and preventative actions, and commissioning practices.
- Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred.
- Demonstrates independence, strong self-motivation, and organization, with the ability to manage multiple priorities in a project-based environment; effective in communication, facilitation, and collaboration.
- Demonstrates a strong team-oriented mindset and actively contributes to a collaborative culture that supports effective decision-making.
- Applies a continuous improvement mindset in daily activities and promotes a strong commitment to safety in all aspects of work.
- Ability to apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, introduction of new equipment, processes, and capital projects. Develop technical solutions to sophisticated problems requiring the regular use of resourcefulness and creativity.
- Develops contingency plan for potential obstacles or setbacks
- Mentorship experience with peers or new team members on complex systems, equipment, machines, and/or processes within their area of expertise.
- Demonstrates interest in continuous learning opportunities around new tools, techniques, and configurations to enhance their analytical abilities.
- Strong leadership, technical writing, and communication/presentation skills are required.
- Required flexibility to support 24/7 operations, including scheduled weekend shifts, after-hours coverage, and on-call rotation.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Frederick National Laboratory for Cancer Research

Post Doctoral Fellow, Organoid Engineering/Biophotonics

**Post Doctoral Fellow, Organoid Engineering/Biophotonics**

Job ID: req4664

Employee Type: nonexempt full-time

Division: Laboratory Animal Science Program

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Laboratory & Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for laboratory and animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of husbandry, veterinary, state-of-the-art technology, and pre-clinical scientific services. LASP also provides primary support to the NIH Standardized Organoid Modeling (SOM) Initiative to address the need for validated, scalable, and reproducible organoid-based Novel Alternative Methods (NAMs) in biomedical research. Our team provides technical infrastructure, operational integration, and specialized expertise to drive the development and optimization of organoid models of normal (non-cancerous) human tissues derived from a wide range of tissue types and donor sources.

**KEY ROLES/RESPONSIBILITIES**

The Post Doctoral Fellow in the MEAD (Major Equipment and Assay Development) Lab within the Standardized Organoid Modeling (SOM) Center will be responsible for:

- Executing assigned pre-clinical scientific research and/or development strategies.
- Developing methods, techniques and evaluation criteria for obtaining results under supervision.
- Expert knowledge of scientific principles and concepts.
- Contributing scientific and technical expertise through experimental and computational approaches to support the development of novel technologies, inventions, and products..
- Acting as a resource for colleagues with less experience.
- Exercising judgment in troubleshooting experiments and approaches to critical assignments.
- Maintaining broad knowledge of state-of-the-art principles and theories.
- Making major contributions to scientific literature and conferences.
- Considering multiple perspectives and future impact of research and/or development.
- Solving unique and complex problems that have a broad impact on the business.
- May participate in development of patent applications.
- Interfacing with various departments and serving as internal consultant.
- Accountable for meeting pre-set, specific targets which will impact the discipline.

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of a PhD degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency.
- Expertise in tissue engineering or biomedical engineering principles.
- Expert direct experience performing basic and advanced laboratory techniques germane to tissue engineering or biomedical engineering, including advanced microscopy.
- Experience executing laboratory protocols, collecting and documenting experimental data, and maintaining accurate laboratory records.
- Experience operating standard biomedical laboratory equipment and performing routine quality control procedures.
- Experience analyzing and reporting experimental results.
- At least some experience publishing peer-reviewed research articles or similar products.
- Demonstrated expertise in at least one subject area with sustained performance and accomplishment during doctorate work.
- Proficiency with Microsoft Office applications and advanced software for statistical analysis, computational modeling, digital image analysis, or scientific computing
- Must possess basic Microsoft Office skills.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Proficiency in one or more of the following areas: organoid engineering, tissue engineering, biomaterials manufacturing, extracellular matrix processing, bioreactor design and engineering, development of cell-based and/or molecular assays, biomedical optics, bioprinting/biophotonics, and prevascularization approaches.
- Competency in at least one additional area from the list above.
- Proficiency or competency in a total of at least three areas from the list above.

**JOB HAZARDS**

- This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

52,900.00 - 75,863.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

\#LI-LR1

Maryland

Sanofi US

Launch Packaging lead

**Job Title**:Launch Packaging lead

- **Location:** Morristown, NJ

**About the Job**

Our ambition is to become industry leading in sustainable devices & packaging for injectable or solids.

As Launch Packaging Leader, you will be accountable for implementing our packaging vision & mission for new launches projects, execute the packaging strategy, and manage roadmaps and processes for primary, secondary, and tertiary packaging of injectable/solids. You will play a crucial role in achieving the company's ambition to become an industry leader in this specific area. You will work closely with the Global Area Head of Packaging to transform the organization's mindset and create a culture where end-to-end packaging for injectable or solids is part of our DNA and patient-centric approach.

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities**

- Drive45+NPI/new launch projects (solids and injectables) globally, leading a group of packaging engineers to meet Launch Project milestones on time, on budget and on quality (95% execution adherence).

- Lead packaging design and development for New Product Launches (NPL), driving innovation and sustainability across the portfolio, with 100% of newly developed packaging assessed against the 3Ps framework (Patient, Planet, Performance).

- Lead content and technical documentation standards for new product registrations (NCEs), ensuring filings meet global regulatory requirements and project timelines.

- Provide technical packaging leadership and analysis to R&D, Regulatory, manufacturing sites for the registration of products worldwide, representing GDPU and M&S on Global Project Teams and CMC sub-teams.

- Direct innovation programs for the search, evaluation and introduction of new packaging technologies to improve quality and compliance, advance sustainability (Eco-designinitiatives), improve efficiencies, reduce costs, eliminate waste and maintain supplycontinuity. Promotea culture of end-to-end packaging for injectable or solid within GDPU and related departments through communication, education, and recognition programs.

- Manage and develop the team responsible for launch packaging development.

**About You**

**Basic Qualifications**

- Bachelors degree in engineering, materials science, pharmaceutical sciences or other relevant scientific discipline.

- Minimum of 10 years of experience in driving packaging launch initiatives, packaging engineering or other related fields.

- Proven track record in managing injectable or solid packaging projects and teams

- Demonstrated ability to influence across functions and external networks, excellence in collaboration, and flexibility in approach

- Strong understanding of regulatory requirements for injectable or solid product packaging

**Languages:** Fluent in English, French is a plus

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.

- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeksgender-neutral parental leave.

- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale

- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#VHD

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

New Jersey

HVAC and Utilities Engineer

**Job Title**: HVAC and Utilities Engineer

- Location: Framingham, MA

**About the Job**

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities:**

- Jointly define with our Facility Management partner the optimal maintenance strategy to guarantee performance.
- Contribute to the design strategy by participating in the development of technical standards.
- Ensure regulatory compliance of equipment submitted and have any reservations resulting from inspections lifted. Ensure reporting to consolidate the site's regulatory situation.
- Anticipate developments (regulatory, technical, etc.) likely to influence the site's activities/performance.
- Analyze, advise, and make recommendations to improve the efficiency and effectiveness of technical solutions implemented.
- Challenge service delivery performance.
- Participate in deviation and root cause investigations as required.
- Communicate issues & resolutions to management, peers & maintenance team.
- Process Improvement Initiatives.
- Vendor Management.
- Own and support closure of HSE and Deviation CAPA Action Plans.
- Responsible for Emergency Response in the areas and systems they own.
- Participate in GOGEMBA site walk and own assigned GEMBA Actions.
- Help Hard Services Contract Supervisor and Head of Facility in monitoring and meeting KPI metric targets and compliance requirements in HSE, Quality and Work Management.

**About You**

**Basic Qualifications**

- Bachelor of Science degree in Engineering, Facilities Management, Mechanical Engineering, or related field with 3+ years of industry experience
- Extensive experience establishing and maintaining safe work practices in current Good Manufacturing Practice (cGMP) environments
- Wastewater Treatment Plant experience is preferred.
- Massachusetts Wastewater Treatment Plant Operator License preferred, or willigness to obtain.
- HVAC license preferred
- Refrigeration or EPA certificate preferred

**Core Competencies:**

- Demonstrated excellence in written and verbal communication across all organizational levels
- Proven ability to collaborate effectively in cross-functional team environments

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Jazz Pharmaceuticals, Inc.

Senior Manager, KOL & External Engagement Platforms Technical Lead

**If you are a current Jazz employee please apply via the Internal Career site.**

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit [www.jazzpharmaceuticals.com](<https://www.jazzpharmaceuticals.com>) for more information.

At Jazz, we are reimagining how we design and deliver more precise customer experiences, enabled by new technologies, modern ways of working, and high performing team behaviors. Through this work, we enable teams to better understand patients, caregivers, and HCPs, anticipate their needs across the enterprise, deliver timely and personalized engagement, and orchestrate seamless, end-to-end experiences as One Jazz.

To power this ambition with both speed and scale, we are embracing a new product-oriented operating model, allowing business and technology teams to partner side by side in building, advancing, and delivering global capabilities across our enterprise. Cross-functional, empowered Global Capability teams own outcomes—not just outputs—and work from clear capability visions, strategies, and measurable goals. We prioritize user problems, validate solutions through experimentation and data, and iterate quickly to create real value for our users and the business. As part of this model, you’ll collaborate closely with users, stakeholders, and technical teams across the organization, using discovery and delivery practices to ensure we’re building the right things, in the right way, at the right time.

The Tech Lead, KOL & External Engagement Platforms, provides hands-on technical leadership and solution design expertise for the KOL & External Engagement Platforms Global Capability team within the Customer Operations function. Reporting to the Technical Suite Lead, this role serves as the primary technical leader for the capability, partnering closely with the Product Owner, Activation Lead, development teams, and/or vendor teams to ensure capability priorities and global standards.

The KOL & External Engagement Platforms team enables the planning, execution, and performance tracking of events, congresses, speaker programs, and broader engagement activities across KOLs, HCPs, patients, and caregivers. As the Tech Lead, this role is a hands-on contributor and technical leader, directly involved in designing, building, and delivering solutions for engagement and event management platforms alongside the development team, bringing technical depth and leadership to every stage of the work.

**Essential Functions/Responsibilities**

**Key Responsibilities:**

**Strategy & Technical Roadmap Development**

- Partner closely with the KOL & External Engagement Platforms Global Capability Owner to support the design of solutions that solve business problems, providing technical insight on what the technology can and cannot do, effort levels, and tradeoffs.

- Collaborate with the Customer Operations Technical Suite Lead and Architects to contribute to translating capability roadmaps into scalable technology architectures and development plans while assessing feasibility, constraints, dependencies, and risks.

- Convert complex business requirements into clear technical specifications and executable technical work tasks.

**Solution Architecture & Technical Delivery**

- Execute technical activities for the technical team and drive work plans, building, configuration, and integration of software aligned to business needs and technology standards, including:

- HCP EngageNow, Veeva Events Portal, and similar engagement platforms, enabling planning, coordination, and tracking of KOL, HCP, and patient engagement activities.

- Event and congress management platforms (e.g., SpotMe, Cadence), supporting execution and measurement of large-scale events and speaker programs.

- Integration frameworks, enabling connectivity between engagement platforms, CRM systems, analytics platforms, and compliance systems.

- Translate technical requirements into well‑defined work for the development team, lead agile ceremonies, and ensure disciplined execution of the capability roadmap, taking ownership of complex technical challenges end to end.

- Coordinate development teams in integrating engagement platforms with upstream and downstream systems (e.g., CRM, web, analytics platforms).

- Ensure solutions meet compliance, auditability, and regulatory requirements for external engagement and healthcare interaction workflows.

- Apply and reinforce standard engagement workflows across brands, markets, and channels.

- Enable automation and optimization of engagement processes to improve efficiency and user experience.

**Cross-Functional Technical Leadership**

- Partner with business, IT security, and vendor teams to ensure the KOL & External Engagement Platforms team technical solutions adhere to organizational standards, security policies, and regulatory requirements.

- Organize and direct vendor partners to execute technical work, ensuring alignment with capability priorities, delivery timelines, and enterprise standards.

- Partner with the Technical Suite Lead, Customer Operations, to escalate and resolve complex technical challenges that span across Global Capability teams.

- Mentor and guide software engineers and developers, elevating the team's overall technical capability.

- Lead cross-team problem solving and resolution of technical challenges within the Global Capability team.

**Required Knowledge, Skills, and Abilities**

**Technical Skills**

- Experience designing, testing, deploying, operating, and enhancing scalable, secure, and compliant technology solutions for large scale organizational use.

- Understanding of enterprise software architecture, cloud platforms, and modern engineering frameworks. Knowledge of system integration patterns, APIs, and data architecture across enterprise technology platforms.

- Knowledge of KOL identification and engagement strategies, event execution workflows, HCP compliance and consent requirements, speaker program management and governance, and performance tracking frameworks.

- Ability to translate engagement strategies into durable, reusable data and platform capabilities. Experience managing vendor‑heavy ecosystems, including roadmap alignment, integration standards, and delivery accountability. Ability to integrate engagement platforms with CRM, analytics, and data platforms for measurement and optimization.

- Strong understanding of event and engagement management platforms, KOL identification and engagement tools, and vendor-supported engagement solutions. Experience designing and integrating enterprise digital platforms such as Veeva Events Portal, SpotMe, Cadence, HCP EngageNow, IFI/MB4, and Patient Advocacy/Conference Engagement Tools.

- Preferred: Proven experience as a full-stack application builder for external-facing (customer / consumer) apps, with track record of partnering closely with business teams. Ability to design scalable KOL and external engagement capabilities beyond just integrating tools.

- Ability to partner with Global Capability Owners to translate executive and Franhcise requirements into scalable, well￼governed technology solutions with roadmaps and prioritization. Provide technical leadership on standardization, KPI implementation, and architectural trade￼offs to ensure enterprise technology assets remain consistent, performant, and extensible across brands and regions.

- Experience leading mixed teams of internal developers and vendors, including technical direction, code and dashboard reviews, estimation, and delivery accountability. Proven ability to collaborate with UX researchers and UI designers, with user-centric mindset applied to technical development.

- Experience working within Agile product development teams and product operating models.

**Business Skills**

- **Customer Journey Understanding** – ability to see customer’s end-to-end experience clearly and use it on an ongoing basis for go to market strategic, tactical and measurement decisions, while anticipating needs across touchpoints. Make practical decisions that improve journey and outcomes.

- **Digital-first Mindset** — ability to look for opportunities to streamline and improve the customer experience and Jazz performance through digital tools, data and automation to create better, faster and more scalable outcomes

- **Cross functional Matrix Collaboration –** ability to work fluidly across teams and reporting lines respecting SME, coordinating shared work, ensuring progress even when accountability is distributed – supporting decisions with professional alignment and focus on collective success. Deeply understands and values unique capabilities and perspectives of diverse functions.

- **Critical Thinking -** The ability to assess a range of inputs objectively, challenge assumptions with curiosity, and generate sound, forward‑looking judgments that improve decisions.

- **Adoption** — ability to quickly embrace new tools, new WoW, and behaviors applying with confidence and practical improvement

**Required/Preferred Education and Licenses**

**Qualifications:**

- Bachelor's degree in computer science, engineering, information systems, or related technical field.
- 7+ years of experience after Bachelor's degree (or 5+ years of experience after Master's degree) in customer engagement, KOL management, event and congress operations, patient advocacy, or related domains in pharma, with expertise in engagement platforms, speaker programs, and compliant customer experience delivery across HCPs, patients, and caregivers.

- 2+ years of experience as a Tech Lead, Technical Program Manager, Engineering Manager, or other roles involving managing a team of developers.

- Expertise in engagement platforms, speaker programs, and compliant customer experience delivery across HCPs, patients, and caregivers

- Demonstrated experience designing and delivering enterprise-scale digital platforms such as engagement platforms, event management systems, CRM-integrated solutions, or external interaction management systems.

- Experience working within complex, matrixed organizations with multiple technology and product teams.

- Proven ability to mentor and guide developers and vendor partners to deliver high-quality solutions.

**Preferred / Additional Qualifications:**

- Experience in pharmaceutical or healthcare industries preferred.

- Experience partnering with enterprise platform teams or Product teams supporting digital and operational capabilities.

- Experience working in rare disease or specialty brands, with strong understanding of unique stakeholder dynamics.

**Working Requirements:**

- 10-20% travel will be required.

**Jazz Expected Behaviors**

- **Demonstrates ownership and accountability**, taking responsibility for outcomes and driving work forward with urgency, clarity, and a focus on impact.

- **Leads with curiosity and a Growth Mindset**, actively exploring user needs, emerging technologies, and new ways of working to elevate capability and innovation.

- **Embraces change as a learning opportunity**, adapting quickly, modeling resilience, and helping others navigate dynamic environments.

- **Acts with a One Jazz mindset**, prioritizing enterprise value, breaking down silos, and building strong, trust-based partnerships across teams.

- **Delivers high performance results**, setting ambitious goals, challenging assumptions, and consistently driving measurable business impact.

- **Models inclusive, collaborative leadership**, creating space for diverse perspectives and empowering others to contribute their best work.

- **Invest in continuous learning**, developing personal skills while coaching and elevating the capabilities of colleagues and cross functional partners.

- **Navigates ambiguity with confidence**, using sound judgment, data, and user insights to make informed decisions even when information is incomplete.

- **Communicates with clarity and influence**, simplifying complexity, aligning stakeholders, and ensuring shared understanding of priorities and outcomes.

\#LI-SP1

\#LI-Remote

*Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.*

**FOR US BASED CANDIDATES ONLY**

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $141,600.00 - $212,400.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: [https://careers.jazzpharma.com/benefits.html](<https://careers.jazzpharma.com/benefits.html>).

Pennsylvania

Eli Lilly and Company

Associate Director Value Chain Leader

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Job Position Overview**

Lilly’s product commercialization spans a growing global manufacturing network, dozens of specialized functions, and an expanding portfolio of transformative medicines. The gap: no single leader owns the full picture.

The Value Chain Leader is the single leader that owns the full picture. You are the single point of accountability for a product’s entire manufacturing commercialization lifecycle. You own the manufacturing CMC strategy, lead the Value Chain Team, collaborate with development, and serve as the go-to interface for senior executives who need clarity.

This is a strategic leadership role, not a coordination role. It demands deep pharma development and/or manufacturing knowledge, executive presence, and the ability to drive alignment across a powerful, matrixed organization—without direct authority.

What Success Looks Like:

Lilly’s commercialization process involves deep, specialized functions—Development, Engineering, Analytical, Quality, TS/MS, Supply Chain, Manufacturing Sites, and CMC Regulatory. Each brings critical experience. The winning Value Chain Leader orchestrates a team: knowing when to convene the full team, and when to engage only who is needed—protecting expert time and driving efficient progress. In year one, and consistently thereafter, you will demonstrate:

- Stakeholder orchestration credibility—functional leaders trust that when you call them in, it matters; when you do not, it is handled.

- A Mfg. Technical Agenda that serves as the true single source of truth—every relevant function’s input synthesized into one coherent product strategy.

- At least one major bottleneck resolved through smart, targeted convening—the right people in the room, no one else.

- Senior leaders who say you “always know where the product stands”—earned through disciplined intelligence gathering, not reporting overhead.

- A Value Chain Team operating with more speed and purpose than before—siloed expertise channeled into coordinated, forward momentum.

**Key Responsibilities**

This role leads moderately complex programs. At times, this role may also partner with a Sr Director Value Chain Leader to deliver highly complex program(s).

Manufacturing CMC Strategy and Commercialization Ownership

- Own the Manufacturing CMC Commercialization Strategy across Development, Manufacturing, and the Business Unit(s).

- Lead the Value Chain Team and oversee its technical execution, ensuring clear ownership, milestone accountability, and proactive risk management.

- Drive alignment of launch presentation and commercial image strategy across relevant functional and affiliate stakeholders.

- Ensure gate deliverables are clearly defined, plans are in place, and execution is on track—proactively identifying and resolving gaps.

Governance and Executive Visibility

- Serve as the accountable representative for the product/program at all Governance and Oversight Forums, providing clear, confident updates on progress, risks, and decisions required.

- Act as the primary interface for senior executive seeking visibility into commercialization status—translating technical complexity into concise actionable insight.

- Ensure escalations are surfaced proactively and resolved with appropriate speed and rigor.

Cross-Functional Alignment and Stakeholder Leadership

- Ensure sustained alignment across Development, Manufacturing, and Business Unit stakeholders throughout the product’s lifecycle, including global manufacturing site teams and CMC Regulatory.

- Influence without authority across a complex, matrixed organization—building trust, resolving conflict, and driving decisions through collaboration rather than directive.

- Partner closely with Development and CMC Regulatory on submission strategy, ensuring the manufacturing program supports regulatory timelines and requirements.

Post-Launch Technical Agenda

- Lead Post-Launch Technical Agenda strategy for assigned products, influencing pre-submission deliverables and lifecycle management planning.

- Ensure the product(s) long-term commercial and technical sustainability by driving proactive planning for process improvements, line extensions, and continuous manufacturing optimization.

**Basic Qualifications**

Education Level

- Minimally, a bachelor’s degree in chemistry, biology, engineering, or Related Scientific Degree

- Preferred: Advanced Engineering, Scientific Degree (M.S., Ph.D., or MBA with strong technical foundation required).

- Additional Preference: PMP Certification, Masters Project Management

Experience

- Minimum 7 years of progressive pharmaceutical industry experience, with meaningful exposure to development, manufacturing, commercialization, and/or technical program leadership.

- Demonstrated experience leading or significantly contributing to cross-functional programs through key development and commercialization milestones (e.g., tech transfer, process validation, regulatory submission readiness, product launch).

- Proven ability to influence and lead without direct authority across complex, matrixed organizations.

- Track record of operating effectively at the senior leadership level—communicating with confidence, handling ambiguity, and making high-quality decisions under pressure.

Functional Background

- TS/MS, CMC Development, Operations, Supply Chain, or Mfg.

**Additional Skills / Preferences**

Key Skills and Competencies

- Strategic Leadership: Shapes long-range manufacturing CMC commercialization strategy; translates vision into execution.

- Influence without Authority: Drives alignment and decisions across powerful, matrixed stakeholders without formal reporting relationships.

- Executive Communication: Distills complex technical and operational information into clear, confident narratives for senior audiences.

- Negotiation and Conflict Resolution: Balances competing functional and affiliate priorities with fairness, speed, and strategic judgement.

- Commercial Acumen: Understands the business implications of manufacturing decisions—including supply risk, launch readiness, and lifecycle value.

- Risk Management: Proactively identifies, surfaces, and resolves program risks before they become schedule or quality issues.

- Cross-Cultural and Global Collaboration: Effective working across global manufacturing sites, development organizations, and business units with varying priorities.

- Entrepreneurial mindset: Comfortable operating in an evolving role structure; builds credibility and process from the ground up.

**Additional Information**

Travel Percentage (%)

Some travel (domestic and international) may be required. (approximately 10-20%)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$118,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Director Engineering - Synthetic Molecule Design and Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are necessary to bring the next generation of life changing medicines to patients.

**Position Summary:**

Our team is looking for experienced, creative, and energetic candidates to lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers.

**Responsibilities:**

- Possess fluent knowledge in unit operation design, process modeling, process equipment selection, and scale-up methodologies with a drive to challenge existing methods; create and apply cutting edge technology and novel platforms within a time constrained environment.
- Familiarity and working knowledge of modern synthetic organic chemistry.
- Demonstrate high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines; be able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities.
- Lead and/or supervise the design and development of new synthetic routes for the manufacture of active pharmaceutical ingredients using the most modern technologies, including continuous processing, automated reaction screening, PAT, and modeling and simulation.
- Ability to lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver a challenging portfolio.
- Comfortable with scientific uncertainty and the ability to translate hypotheses into action.
- Encourage team members to take initiative and accountability to achieve goals; draws out and encourages others to share knowledge.
- Provide technical guidance in the scale-up and demonstration of new chemical processes in development and commercial scale equipment. Participate in technology transfer activities to CRO/CMO organizations and Lilly manufacturing to ensure processes are technically sound, well developed and characterized, and safe.
- Design laboratory experimentation in support of process design, definition, optimization, and technology transfer objectives. Ability to generate process (and property design) data based on a fundamental understanding of the underlying physical processes. Utilize advancements in technology (PAT) and modeling platforms to understand and direct experimental protocols.
- Plan and manage short term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
- Collaborate with internal and external manufacturing partners to develop robust chemical process that are readily amenable to efficient drug substance manufacturing.
- Collaborate closely with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory scientists to execute and deliver material and information for clinical trials and regulatory submissions.
- Embrace diverse thought, background, and experience to deliver innovative solutions.
- Possess strong communication (oral, written), organizational, and leadership skills.
- Supervise, mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
- Active participant in the external environment and the ability to recognize and apply external innovation and across the Lilly synthetic portfolio.
- Possess deep understanding of the external global regulatory climate and emerging requirements. Ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.

**Basic Qualifications:**

- Ph.D. in chemical engineering or a closely related field with 8+ years of experience; or MS degree with 15+ years of experience.
- Experience developing chemical processes the from mid-development cycle (proof of concept) to product commercialization required
- Experience with technical transfer of processes into manufacturing operations required

*\*Experience within the pharmaceutical sector is desired; however, other relevant experience may meet expectations. Prior experience in the development of an active ingredient and associated formulated product is acceptable. Relevant industrial sectors include agrochemicals, nutraceuticals, specialty chemicals, and personal care products.*

**Additional Skills/Preferences:**

- Experience with authoring regulatory submissions and responding to regulatory questions.
- Experience with modeling and simulation tools, data analytics, and predictive analytics.
- Experience with online and offline analytical techniques and process analytical technologies (PAT).
- Strong technical skills to supply business value.
- Creativity and ability to transform ideas into marketable products and processes.
- Knowledge and experience with management of a technical project.
- Demonstrated leadership capabilities especially in a team environment.
- Demonstrated ability to drive and accept change.
- Demonstrated success in persuasion, influence and negotiation.
- Good interpersonal skills and a sustained tendency for collaboration.
- Ability to prioritize multiple activities and manage ambiguity.
- Ability to influence others to promote a positive work environment.
- Understanding and awareness of the external scientific and regulatory landscape.
- Demonstrated initiative and risk-taking.
- Demonstrated technical proficiency and ability to create ideas for future work plans.
- Established external publication record.

**Additional Information:**

- Travel: 0 -10%
- Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$151,500 - $264,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Engineer - Design Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Overview**

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering and Continuous Improvement, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will support an expansion in supply of existing medicines or making the supply chain more robust. The Design Lead (DL) will serve in the following capacity:

**Responsibilities:**

- Lead in the identification of the applicable Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements and guidance (both internal and external).
- Be responsible for the overall design delivery for capital project(s).
- Coordinate all design for the Project Manager during all design phases of the project and be responsible in delivering the conceptual design review and basic design review.
- Direct the development of the design requirements.
- Assist in development and maintenance of the design schedule to meet the project needs.
- Participate in the selection of the A/E firms.
- Coordinate with A/E firms to develop earned value progress systems to measure progress by discipline (monitor work versus invoice amounts).
- Expedite design decisions and coordinate information flow between the design team and system owners.
- Be responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer.
- Be responsible for design activities and governance, resolving design-related problems.
- Examine areas of inefficiency and develop strategies for improvement to direct the design team to meet or improve on the design hours plan.
- Assist in the development of standard operating procedures, project delivery work instructions, and/or best practices related to design/verification and ensure they remain current with industry best practices.
- Review and approve along with the respective Project Manager the key design project personnel (both internal and external resources).
- Work with Engineering Tech Center resources and other key project team technical/constructability resources to address and resolve design issues.
- Ensure replication is achieved during design when applicable.
- Support the Project Manager for value engineering exercises efforts to maximize project opportunities.
- Review design-related invoices prior to approval and participate in KPI reviews/assessments.
- Participate in the selection of the verification professional services.

**Basic Requirements:**

- BS in Engineering.
- Minimum of 10-years manufacturing and/or engineering experience in support of pharmaceutical or API (active pharmaceutical ingredient) networks.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- BS in Chemical or Mechanical Engineering.
- Pharmaceutical process or project engineer experience.
- Strong project management skills.
- Ability to effectively facilitate conflict to resolution.
- Ability to influence all levels of the project and site personnel.
- Understanding of the capital project delivery process, A/E design activities, and the understanding of the available Lilly technical resources (user reps, Engineering Tech Center resources, and design specialists).
- Demonstrated values that are consistent with the Lilly values.
- Able to frame complex decisions/analyses, facilitate to a decision, and implement according to the plan.
- Ability to create creditability and influence to align decision agreements between site(s), corporate engineering, A/E firm decision-makers, and stakeholders who have differing opinions.
- Experience facilitating issue resolution, anticipating scope changes, and implementing projects safely with quality, speed and value.
- Willingness to relocate and/or travel to locations outside of home state/country and have the demonstrated ability to work from long distances with little supervision.

**Additional Information:**

- Travel can be both domestic and international, on average about 25%, depending on the phase of the project.
- The potential of co-location at the A/E firm or the job site to support C&Q activities for periods of time could occur based on project needs.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

GRAIL Inc

Staff Software Engineer - Commercial - #4903

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit [grail.com](<http://grail.com/>)

Grail is looking for a Staff level full-stack engineer who enjoys working on a broad array of software systems and projects. The team is responsible for patient-facing software used for [The Galleri® Test](<https://www.galleri.com/hcp/the-galleri-test>) as well as gathering clinical data. We strive to build a robust and scalable infrastructure as well as easy-to-use UI interfaces. Our technical stack consists of Go, AWS, Kubernetes, Microservices, and React.

This role is based in Sunnyvale, California. GRAIL offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site. At our Sunnyvale, CA campus, Tuesdays and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities. We may also consider candidates in Durham NC but the bay area is preferred.

**Responsibilities**

- Use your experience developing backend applications and distributed systems to build native cloud-based software that is leveraged by GRAIL’s key commercial offerings for the Galleri® Test , my.grail.com and provider.grail.com
- Develop and lead multiple large cross-functional / cross-organizational programs with high complexity, resource requirements and associated risks.
- Drive improvements for the software engineering organization based on understanding of business needs and industry trends
- Provide technical leadership in the form of standards, tools, and knowledge requirements for the software engineering organization
- Guide and mentors team members to provide an example of innovation and excellence

**Required Qualifications**

- Bachelor's or Master's degree in Computer Science, Electrical Engineering, Bioinformatics, or similar technical field or equivalent experience.
- 8-12+ years of meaningful work experience designing, developing, testing, and maintaining full-stack applications and microservice ecosystems.
- Excellent knowledge of:
  - **Programming Languages:**  Go (preferred), Java, Python, JavaScript, C++
  - **Frontend:**  React, Angular
  - **Backend:**  Spring, Spring Boot, REST APIs, gRPC (preferred)
  - **Cloud & DevOps:**  AWS (preferred), GCP, Azure, Kubernetes, Docker, Terraform (preferred), Microservices
  - **Data:**  PostgreSQL, MySQL, Redis
  - **Development Practices:**  CI/CD, Automated Testing, Agile Development
- Experience developing distributed systems on one of the cloud platforms like AWS, GCP, or Azure.
- Experience with writing and executing test protocols
- Passion for designing and building practical high-quality software solutions.
- Strong professional written and verbal communication skills.
- Familiarity with gRPC, terraform, AWS is a plus
- Willingness to add value to the team!

These job duties summarize the primary responsibilities of the position and are not intended to be a comprehensive listing of all duties. Responsibilities may change based on business needs.

The expected, full-time, annual base pay scale for this position is $169k-$224k.

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at \[email protected\] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Aspen Neuroscience

Sr. Automation Engineer

Aspen Neuroscience is at the forefront of autologous stem-cell therapies, and we are looking to add a Senior Automation Engineer to our growing team. The Senior Automation Engineer will support the development, improvement, maintenance, and operation of complex custom automation systems in a biotech environment. They will bring a multi disciplinary, collaborative approach and strong software and problem-solving skills to help prevent and solve issues with the automation equipment. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

**DUTIES AND RESPONSIBILITIES:**

- Understand system requirements, operational scenarios, and success criteria for a variety of automation systems.
- Develop scripted protocols for machine operation that align with the biological process needs.
- Support system integration efforts across hardware and software components, ensuring seamless interoperability.
- Help develop and implement verification and validation plans, including functional testing, to ensure compliance with requirements.
- Troubleshoot and identify root causes of failures in automation systems where up time is paramount.
- Create and maintain essential engineering documentation and system specifications.
- Understand and ensure compliance with industry standards, regulations, and internal quality processes.
- Collaborate with cross-functional teams, stakeholders, and key opinion leaders to ensure seamless integration and successful project delivery

**EDUCATION AND EXPERIENCE:**

- Minimum BS in Biomedical, Computer, Mechanical, Electrical, or Systems Engineering.
- Minimum 5 years’ experience in the hardware design, automation or biotechnology industry.

**JOB SPECIFICATIONS**:

- **Automation Engineering Knowledge:**  Understanding of automation engineering principles, algorithms, system architecture, and interest in emerging technologies, particularly within the custom automation environment.
- **Problem Solving:**  Strong engineering intuition with the ability to analyze complex issues and implement rigorous, logical solutions.
- **Software Integration:**  Proficiency working in a C# codebase and experience with integration and testing of automated systems.
- **Hardware & Automation Technologies:**  Experience with hardware systems such as robotics, motion platforms, controls, sensors, and machine vision.
- **Communication & Collaboration:**  Excellent written, verbal, and presentation skills with the ability to convey technical concepts to diverse stakeholders.
- **Process Orientation:**  Strong attention to detail with a commitment to process discipline, documentation, and continuous improvement.
- **Regulatory Awareness:**  Knowledge of GxP principles and familiarity with FDA regulations (21 CFR Parts 11, 210, 211, 820) is desirable.
- **Mechanical Systems:**  Familiarity with statics, dynamics, and motion control.
- **Electronic Systems:**  Skilled in integration of electronic components, electric motor control, custom/off-the-shelf hardware selection, troubleshooting and system safety.
- **Safety:**  Establishing and following safety guidelines for machinery and procedures.

**WORKING CONDITIONS**

General Office Environment. This is an indoor position that requires sitting at a desk for extended periods of time and the ability to type and use a computer. The noise level in the work environment is usually quiet to moderate. Some Cleanroom access is required

**PHYSICAL DEMANDS**

While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. These work environment characteristics are representative of the environment the jobholder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.

**EEO and Employment Eligibility:**

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

**Total Rewards and Culture:**

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks. The anticipated salary range for candidates who will work in San Diego is $135k-$165k annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.

Intellia Therapeutics

Senior Scientist - Small Molecule and Oligonucleotide Process Sciences

**Why Join Intellia?**

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

**How You Will Achieve More:**

As a successful candidate you will join the sgRNA Process Development Group as part of the larger Oligonucleotide and Lipid Process Sciences team within Technical Operations/CMC. As SME for the sgRNA upstream process and process chemistry you will be providing technical and operational support across all life-cycle stages for Intellia’s assets from emerging pipeline through commercial-stage activities. You will help drive process design, development, characterization and finally tech transfer of GMP-ready processes while serving as a key technical partner across cross-functional teams within Intellia and with external partners as needed. In this role you are expected to mentor junior staff and drive continuous improvement across our processes and operations.

**Responsibilities:**

*Process Development & Technical Execution*

- Lead development, optimization and characterization of solid-phase oligonucleotide synthesis (upstream focus), with emphasis on scalability and tech. transfer (OP100 scale)
- Design and execute process characterization studies/DoEs and troubleshoot analytical data
- Support downstream purification processes to improve yield, purity, and reproducibility
- Support MSAT team with tech transfer and process validation activities as well as continuous process verification as needed

*Operational Execution & Documentation*

- Track milestones, dependencies, and risks across concurrent PD workstreams
- Manage day-to-day lab resourcing and prioritization
- Coordinate with external manufacturing & supply chain as well as CDMOs in support sgRNA and lipid manufacturing as needed
- Author and review SOPs, batch records, development reports, sections for regulatory filings as well as process validation and change control documentation

*Mentorship & Collaboration*

- Represent Process Development and provide updates to cross-functional teams using effective communication to both technical and non-technical audiences
- Serve as the team process chemistry SME across the matrix for oligonucleotide and small molecule synthesis; mentor and train junior scientists; and collaborate with stakeholders that support other modalities.

**About You:**

- Solid expertise in phosphoramidite and oligonucleotide process chemistry with hands-on experience in automated synthesizers (OP100, Oligosynt platforms) and HPLC
- Strong organic chemistry foundation with working knowledge in small molecule manufacturing processes is an advantage
- Proficiency in HPLC and LC-MS for oligonucleotide characterization and analytical troubleshooting
- Excellent technical writing skills; track record of authoring SOPs, reports, and regulatory documents. Being highly organized with ability to manage multiple concurrent workstreams and drive priorities independently
- PhD in Organic Chemistry, Biochemistry, Biotechnology, or related field
- MS or BS in a related scientific discipline
- Ph.D. or M.S. in Chemistry, Organic Chemistry, Nucleoside Chemistry or related discipline with minimum 2 (PhD) or 8 (M.S.) years' experience, preferably in oligonucleotide field.
- Hands-on experience with solid-phase oligonucleotide synthesis and operation of lab-scale synthesizers; familiarity with GxP operations, quality systems and the pharmaceutical development lifecycle
- Experience driving multiple workstreams internally with cross-functional stakeholders as well as with external partners

\#LI-On-Site

**_EEOC Statement:_**  *Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.*

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $136,800.00 - $167,200.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please [click here](<https://www.intelliatx.com/careers/join-us/>).

Civica Rx

Process Engineer II (238)

**About Civica:**

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at [**www.civicarx.org**](<http://www.civicarx.org/>)

**Job Description**

The Process Engineer II will play a critical role in bringing the Civica Petersburg, VA facility into a production-ready state, and in facility and equipment design through commercialization for a newly announced facility expansion for biologics. Scope for the expansion includes a dedicated high-speed cartridge filling line, substantial upgrade to critical utilities services, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities.

In the project delivery and startup phase of the project (currently in progress through 2025), the

Senior Process Engineer will be dynamic as we endeavor to support the startup, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

The Senior Process Engineer will act as a bridge between the project planning phase and ongoing operations by assuming System Owner responsibility for one or more manufacturing systems. In this role, the successful candidate will work closely with Validation, Manufacturing, and Quality Assurance to ensure availability, support, and maintenance of those system(s) throughout their lifecycle, and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.

**Essential Duties and Responsibilities**

- You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting.
- Provide technical expertise on CQV activities and ensures compliance to regulatory requirements, industry best practices, and Engineering standards.
- Participate directly in the Engineering process to develop and institute technical and procedural controls in the process design.
- Accountable for CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
- Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
- Anticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.
- Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
- Interpersonal skills to manage interactions and drive results across a range of business functions, education levels, and cultural backgrounds within the site. Extends to external communication with system vendors.

**Basic Qualifications and Capabilities**

- Bachelor’s degree in Engineering required.
- Strong mechanical aptitude.
- Demonstrated ability to solve technical problems and implement projects.
- Excellent interpersonal and communication skills, and fluency in English.
- Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
- Interact well with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects with minimal required direction from his/her supervisor.
- Willingness to adapt to changing priorities as project demands change.

**Preferred**

- 5+ years of experience in sterile injectables, drug-device combination products, or biologics.
- SME-level knowledge of drug product processing equipment (e.g. single-use mixers and stainless steel formulation vessels, parts washers, autoclaves, component processors, aseptic filling equipment – vials, pre-filled syringes, and cartridges – isolators with VPHP decontamination, filter integrity and isolator glove integrity testers).
- Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.
- Familiarity with cleaning validation and/or process validation.
- Previous work at greenfield sites or substantial facility expansion projects.

Virginia

Associate Director Automation (237)

**Job Description**

The Associate Director of Automation develops and implements the site automation strategy and leads a site-based team responsible for the design, implementation, and compliant operation of Civica Petersburg’s automation and industrial control systems (ICS). This includes systems supporting facility, utility, and manufacturing processes across both clinical and commercial operations, as well as close partnership with the IT/OT team to maintain the process control network. Plant systems include DCS, SCADA, PLC, BMS, EMS, data historians, and analytics solutions. As the functional leader, this role sets direction, makes decisions, balances priorities, represents the Automation Engineering function in cross-functional governance and decision-making, and manages cross-functional projects in a fast-paced startup environment. The incumbent is expected to contribute hands-on technical support as needed, provide expertise in manufacturing and compliance standards (including Computerized Systems Validation - CSV), guide team members, and advise key business leaders on automation strategy. This role is accountable for ensuring reliable, compliant, and scalable automation systems that enable efficient site startup and sustained manufacturing performance.

**Essential Duties and Responsibilities**

- Develop and execute the site automation strategy.
- Lead Automation Engineering support for mission-critical manufacturing systems, including data historians, central monitoring systems, process automation, building management, SCADA, and PLC systems.
- Ensure plant execution and operations systems support commissioning, validation, safety, compliance, and quality manufacturing across clinical and commercial production.
- Manage automation engineers and represent Automation Engineering while partnering with IT, Quality, Validation, Manufacturing, Engineering, Technical Services, vendors, and other teams to deliver automation priorities.
- Provide strategic direction and hands-on support for Manufacturing and Operations, including troubleshooting and issue resolution for business-critical needs.
- Set priorities for the site systems technology landscape, including new facilities, system changes, validation lifecycle strategy, and S95/S88 standards, libraries, and systems.
- Build and develop a high-performing team while fostering innovation, quality, compliance, accountability, engagement, collaboration, diversity, and inclusion.
- Maintain inspection and audit readiness for automation systems, including cybersecurity requirements, data integrity, and alarm management.
- Mentor, coach, train, and evaluate automation engineers.
- Implement automation policies, procedures, SOP authorship and oversight, and system support aligned with regulations and industry standards.
- Analyze process issues and recommend corrective and preventive actions.
- Support sitewide cybersecurity alignment and direction.
- Lead continuous improvement efforts, promote best practices, and ensure safety is integral to all activities.
- Serve as an automation SME during regulatory inspections, including FDA and DEA inspections.
- Demonstrate strong leadership, communication, team-building, coaching, budgeting, and resource-management skills.

**Basic Qualifications and Capabilities**

- Bachelor’s degree or similar technical degree required.

- 10+ years of progressive automation or related pharmaceutical industry experience.
- 5+ years of automation execution subject matter expertise.
- Experience developing test plans, user requirements, and system design documents.
- Strong programming and troubleshooting knowledge for Rockwell or Siemens PLCs and HMI platforms, including FTView, GE iFix, and/or Wonderware System Platform.
- Strong knowledge of computerized systems, compliance regulations, and standards, including Computerized Systems Validation (CSV).
- Support the full engineering project lifecycle for sterile injectable automation and instrumentation, from design through commissioning, qualification, troubleshooting, and continuous improvement.
- Collaborate across Operations, Quality, Regulatory, Process Development, Supply Chain, and other GMP manufacturing groups to resolve business-critical issues.
- Demonstrated leadership, team-building, communication, coaching, planning, and organizational skills.
- Strong project and time management skills, with the ability to influence in a matrixed environment and balance production and maintenance needs.
- Ability to forecast and manage departmental budgets and cost center resources.
- Knowledge of SQL, AVEVA PI, database, and historian systems.
- Experience with VMware, virtualization, and basic networking.
- Familiarity with automation platforms, PLCs, SCADA, PI Historian, Industrial Ethernet, Profibus, and AS-I networks.
- Experience in a sterile injectable environment.
- Understanding of biotech data integrity principles and FDA guidance.
- Exposure to batch or continuous pharmaceutical/biotech manufacturing.
- Experience with S88, ASTM 2500, CSV, regulatory inspections, and large capital projects.
- Strong teamwork and organizational skills, with experience using continuous improvement and lean tools.

**Preferred Qualifications**

- Knowledge of SQL, AVEVA PI, database, and historian systems.
- Experience with VMware, virtualization, and basic networking.
- Familiarity with automation platforms, PLCs, SCADA, PI Historian, Industrial Ethernet, Profibus, and AS-I networks.
- Experience in a sterile injectable environment.
- Understanding of biotech data integrity principles and FDA guidance.
- Exposure to batch or continuous pharmaceutical/biotech manufacturing.
- Experience with S88, ASTM 2500, CSV, regulatory inspections, and large capital projects.
- Strong teamwork and organizational skills, with experience using continuous improvement and lean tools.

Automation Engineer I - 1st and 2nd shift (281)

**Job Description:**

Civica is searching for an Automation Engineer on the first or second shift with experience in pharmaceutical drug product manufacturing. The Petersburg site serves as Civica’s new fill-finish facility, dedicated to the manufacture and supply of essential generic sterile injectable medications.

As a member of the IT/OT Automation Team, the successful candidate will be required to support system automation initiatives and perform troubleshooting that requires a good understanding of analytical problem-solving techniques, project management, lifecycle management, network, and virtual environments. The position requires a good understanding of programming, design, installation, and lifecycle management of manufacturing process controls, packaging equipment, aseptic filling lines, automation, industrial networks, virtual environments, and field instrumentation technologies.

**Essential Duties and Responsibilities:**

- We are seeking a skilled individual who thrives in a fast-paced environment to support and implement our Automation solutions across our facility. As an Automation Engineer, your job responsibilities include:
- Supervisory Control and Data Acquisition systems (SCADA), preferably Rockwell’s FactoryTalk View Systems and Siemens.
- Trouble-shoot process control applications (Rockwell and Siemens PLCs) utilizing Programmable Logic Controllers (PLC) and Human Machine interface (HMI)
- Support Rockwell’s Data Historian, Asset Centre, FactoryTalk Directory, etc.
- Support database administration and SQL.
- Troubleshoot day-to-day issues and provide guidance to junior engineers.
- Good understanding of control system philosophy, control system standards, alarms, instrumentation configuration, programming, and design in a cGMP environment.
- Development of detailed specifications, engineering documents, SOPs, test scripts, and engineering standards.
- Effectively interact and collaborate with cross-functional departments, and clients to meet company expectations.
- Independent, self-motivated, organized, able to multi-task in a dynamic environment and embrace a team-based culture that relies on collaboration for effective decision-making.
- Support ownership and administration of process control automation in a GMP-regulated environment.
- Generate and follow proper change control for any automation/process changes within the system.
- Lead root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.
- Support new product introductions or new technology introductions by performing engineering assessments, engineering studies, implementing automation system configuration changes, and supporting engineering runs.
- Design and testing of newly installed and currently installed automation-based process and packaging equipment.
- Assist in the support of network advancements and new technologies as they pertain to networking architectures.

**Basic Qualifications and Capabilities:**

- 3 years of Engineering/Automation experience or associate degree and 6+ years of Engineering/Automation experience (Preferably Electrical or Computer Engineering)
- Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5.
- Knowledge and understanding of Data Integrity and how it applies to the Pharmaceutical Industry with a specific focus on guidelines from the FDA.
- Experience in a GMP environment, change control, nonconformance, corrective and preventive actions, and validation practices.
- Candidates must have hands-on knowledge of at least one major PLC platform: Allen Bradley PLCs (ControlLogix or CompactLogix) Studio 5000 software, or Siemens PLCs (TIA Portal).
- Candidates must have hands-on experience with at least one of the following: working in virtual environments (ESXi version 7.0, VMware Workstation, or virtual network configuration), or batch reporting.

**Preferred Qualifications:**

- Experience in sterile fill-finish facility manufacturing.
- Knowledge of FactoryTalk Directory, FactoryTalk Asset Centre, FactoryTalk Data Historian, Factory Talk View SE & ME, and WIN911.
- Experience of Thin Manager and Clients
- Knowledge in with regulatory inspections.
- Knowledge in control projects and time management.
- Knowledge in change controls and investigations.
- Knowledge in Programming Switches, Firewalls, and designing networking architecture is preferred.
- Knowledge in Thin Manager/Thin Clients, SQL Server design, implementation, and support.
- Experience with BMS, EMS systems, OPC, ODBC, Data Historians, WIN911, as well as Chillers, Boilers, HVAC, Wastewater and other utilities systems.

**Physical Demands and Work Environment:**

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is required to stand; walk; sit; crouch; and reach with hands and arms and access areas with restricted space. The employee is occasionally required to conduct work activities (troubleshooting & installations) in confined spaces following safety guidelines and procedures. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. Work requires occasional after-hours and weekends engineering coverage.

The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.

Automation Engineer II - 1st and 2nd Shift (514)

Civica is searching for an Automation Engineer II with experience in pharmaceutical drug product manufacturing. The Petersburg site serves as Civica’s new fill-finish facility, dedicated to the manufacture and supply of essential generic sterile injectable medications.

As a member of the IT/OT Automation Team, the successful candidate will be required to support system automation initiatives and perform troubleshooting that requires a good understanding of analytical problem-solving techniques, project management, lifecycle management, network, and virtual environments. The position requires a good understanding of programming, design, installation, and lifecycle management of manufacturing process controls, packaging equipment, aseptic filling lines, automation, industrial networks, virtual environments, and field instrumentation technologies.

**Essential Duties and Responsibilities:**

• We are seeking a skilled individual who thrives in a fast-paced environment to support and implement our Automation solutions across our facility. As an Automation Engineer II, your job responsibilities include:

• Supervisory Control and Data Acquisition systems (SCADA), preferably Rockwell’s FactoryTalk View Systems and Siemens.

• Trouble-shoot process control applications (Rockwell and Siemens PLCs) utilizing Programmable Logic Controllers (PLC) and Human Machine interface (HMI)

• Support Rockwell’s Data Historian, Asset Centre, FactoryTalk Directory, etc.

• Support database administration and SQL.

• Troubleshoot day-to-day issues and provide guidance to junior engineers.

• Good understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment.

• Development of detailed specifications, engineering documents, SOPs, test scripts, and engineering standards.

• Effectively interact and collaborate with cross-functional departments, and clients to meet company expectations.

• Independent, self-motivated, organized, able to multi-task in a dynamic environment and embrace a team-based culture that relies on collaboration for effective decision-making.

• Support ownership and administration of process control automation in a GMP-regulated environment.

• Generate and follow proper change control for any automation/process changes within the system.

• Lead root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.

• Support new product introductions or new technology introductions by performing engineering assessments, engineering studies, implementing automation system configuration changes, and supporting engineering runs.

• Design and testing of newly installed and currently installed automation-based process and packaging equipment.

• Assist in the support of network advancements and new technologies as they pertain to networking architectures.

**Basic Qualifications and Capabilities:**

• Master’s degree and 6+ years of Engineering/Automation experience or bachelor’s degree & 8 years of Engineering/Automation experience or associate degree and 10+ years of Engineering/Automation experience (Preferably Electrical or Computer Engineering)

• Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5.

• Experience and understanding of Data Integrity and how it applies to the Pharmaceutical Industry with a specific focus on guidelines from the FDA.

• Experience in a GMP environment, change control, nonconformance, corrective and preventive actions, and validation practices.

• Candidates must have hands-on knowledge of at least one major PLC platform: Allen Bradley PLCs (ControlLogix or CompactLogix) Studio 5000 software, or Siemens PLCs (TIA Portal).

• Candidates must have hands-on experience with at least one of the following: working in virtual environments (ESXi version 7.0, VMware Workstation, or virtual network configuration), or batch reporting.

**Preferred Qualifications:**

• Experience in sterile fill-finish facility manufacturing.

• Experience with regulatory inspections.

• Experience of Thin Manager and Clients

• Experience of FactoryTalk Directory, FactoryTalk Asset Centre, FactoryTalk Data Historian, Factory Talk View SE & ME, and WIN911.

• Experience in control projects and time management.

• Experience in Change Controls and investigations.

• Experience in Programming Switches, Firewalls, and designing networking architecture.

• Experience in Thin Manager/Thin Clients, SQL Server design, implementation, and support.

• Experience with BMS, EMS systems, OPC, ODBC, Data Historians, WIN911, as well as Chillers, Boilers, HVAC, Wastewater and other utilities systems.

**Physical Demands and Work Environment:**

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is required to stand; walk; sit; crouch; and reach with hands and arms and access areas with restricted space. The employee is occasionally required to conduct work activities (troubleshooting & installations) in confined spaces following safety guidelines and procedures. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. Work requires occasional after-hours and weekends engineering coverage.

The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.

Maintenance Technician, Process Equipment (# 318, # 605)

**About Civica:**

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

*Who suffers most? Patients.*

**Civica** is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at [www.civicarx.org](<http://www.civicarx.org/>)

**Position Summary**

The Maintenance Technician, Process Equipment is responsible for driving compliant results in a GMP pharmaceutical manufacturing environment by directly supporting a wide range of service disciplines covering pharmaceutical process equipment such as, but not limited to: fill lines, isolators, parts washers, autoclaves, container closure processing equipment, formulation vessels, labeling equipment, and various lab equipment utilized in the production environments. The Maintenance Technician, Process Equipment, operates in a highly technical environment that requires experience specifically in maintaining safe and reliable production activities. The Maintenance Technician, Process Equipment, applies critical thinking and considers all business-impact factors before taking job-related actions that could lead to unintended consequences, such as unsafe events, equipment failure, and other risks. The Maintenance Technician, Process Equipment, should be able to apply independent judgment and perform in a small-company environment where rapid changes occur. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive mindset, driving a positive team culture.

These positions follow a 2-2-3, 12-hour day schedule: 6:00 PM-6:30 AM - 2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off.

**Essential Duties and Responsibilities**

- Support the day-to-day production activities in the production area. First line of response in case of production equipment malfunction.
- Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
- Partner with engineering, calibration, and spare parts teams to ensure proper inventory of key spare parts.
- Partner with engineering in the development and/or revision as required, of preventive maintenance (PM) instructions of production equipment.
- Support the coordination and execution of calibrations and preventative maintenance activities.
- Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors as needed to reach problem resolutions.
- Proactively work with supports teams Ein developing solutions for equipment issues.
- Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner.
- Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
- Collaborate with Manufacturing, Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
- Support the onboarding and technical training of Manufacturing staff on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and formulation vessels.
- Assist R&D and MSAT on new product introduction and technology transfer activities.
- Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
- Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.
- Periodically on call to monitor and respond to manufacturing equipment repairs and issues.
- Other duties as assigned.

**Basic Qualifications (Knowledge, skills, and abilities)**

- High school diploma with 4 years of experience in executing maintenance to manufacturing equipment, or an associate’s degree or higher in Pharmaceutical Sciences, Engineering, or a related field is preferred.
- Experience with sterile fill-finish manufacturing.
- Knowledge of GMP, regulatory requirements, and industry best practices.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Experience in a continuous process improvement environment, including change management.
- Experience in using Computerized Maintenance Management Systems.
- Strong communication and collaboration skills, committed to meeting high-quality standards.

**Preferred Qualifications**

- Knowledge of high-speed aseptic filling and isolator barrier system technology.
- Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
- Proficiency in Microsoft Office Suite.

**Physical Demands and Work Environment**

The physical demands described here are those an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use their hands or fingers to handle, feel, or control objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations.

Principal Machine Learning Engineer

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Principal Machine Learning Engineer**

**What you will do**

Lets do this. Lets change the world. In this vital role you will Own enterprise AI/ML architecture, standards, APIs, and guardrails across cloud/on-prem.

We are seeking a **Principal Machine Learning Engineer**Amgens most senior individual-contributor authority on building and scaling end-to-end machine-learning and generative-AI solutions. Sitting at the intersection of engineering excellence and data-science enablement, you will develop, deploy and monitor modelsclassical ML, deep learning and LLMssecurely and cost-effectively. Acting as a player-coach, you will establish AI solution strategy, define technical standards, and partner with DevOps, Security, Compliance and Product teams to deliver a frictionless, enterprise-grade AI solutions.

**Roles & Responsibilities:**

- Own enterprise AI/ML architecture, standards, APIs, and guardrails across cloud/on-prem.

- **Build production ML/GenAI solutions** and lightweight apps delivering sub-second insights.

- **Build end-to-end ML pipelines**data ingestion, feature engineering, training, hyper-parameter optimisation, evaluation, registration and automated promotionusing Kubeflow, SageMaker Pipelines, Open AI SDK or equivalent MLOps stacks.

- **Build and maintain full-stack AI applications** by integrating model services with lightweight UI components, workflow engines or business-logic layers so insights reach users with sub-second latency.

- Establish observability, SLOs, and safe deploys (blue-green/canary, shadow, rollbacks) with incident runbooks.

- **Lead rigorous evaluation** (offline/online, A/B), drift detection, and automated retraining.

- **Architect LLM/RAG** with prompt management, safety guardrails, and optimized inference.

- **Enforce data quality**, lineage, and model/data cards; apply privacy-preserving techniques where needed.

- **Contribute reusable ML/GenAI components**feature stores, model registries, experiment-tracking librariesand evangelize best practices that raise engineering velocity across squads.

- **Perform exploratory data analysis and feature ideation** on complex, high-dimensional datasets to inform algorithm selection and ensure model robustness.

- **Prototype and benchmark new algorithms**, offering guidance on scalability trade-offs and production-readiness while co-owning model-performance KPIs.

- Translate domain needs (R&D, Manufacturing, Commercial) into roadmaps; mentor teams and communicate trade-offs.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a **Principal Machine Learning Engineer** with these qualifications.

**Basic Qualifications:**

Doctorate degree and 2 years of **Machine Learning Engineer** experience

OR

Masters degree and 6 years of **Machine Learning Engineer** experience

OR

Bachelors degree and 8 years of **Machine Learning Engineer** experience

OR

Associates degree and 10 years of **Machine Learning Engineer** experience

OR

High school diploma / GED and 12 years of **Machine Learning Engineer** experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

- **3-5 years** in AI/ML and enterprise software.

- Strong command of machine-learning algorithmsregression, tree-based ensembles, clustering, dimensionality reduction, time-series models, deep-learning architectures (CNNs, RNNs, transformers) and modern LLM/RAG techniqueswith the judgment to choose, tune and operationalize the right method for a given business problem.

- Proven track record selecting and integrating AI SaaS/PaaS offerings **and** building custom ML services at scale.

- Expert knowledge of GenAI tooling: vector databases, RAG pipelines, prompt-engineering DSLs and agent frameworks (e.g., LangChain, LangGraph, Semantic Kernel).

- Proficiency in Python and Java; containerization (Docker/K8s); cloud (AWS, Azure or GCP) and modern DevOps/MLOps (GitHub Actions, Bedrock/SageMaker Pipelines).

- Strong business-case skillsable to model TCO vs. NPV and present trade-offs to executives.

- Exceptional stakeholder management; can translate complex technical concepts into concise, outcome-oriented narratives.

**Preferred Qualifications:**

- Experience in Biotechnology or pharma industry is a big plus

- Published thought-leadership or conference talks on enterprise GenAI adoption.

- Masters degree in Computer Science and or Data Science

- Familiarity with Agile methodologies and Scaled Agile Framework (SAFe) for project delivery.

**Education and Professional Certifications**

- Masters degree with 10-12 + years of experience in Computer Science, IT or related field

OR

- Bachelors degree with 12-14 + years of experience in Computer Science, IT or related field

- Certifications on GenAI/ML platforms (AWS AI, Azure AI Engineer, Google Cloud ML, etc.) are a plus.

**Soft Skills:**

- Excellent analytical and troubleshooting skills.

- Strong verbal and written communication skills

- Ability to work effectively with global, virtual teams

- High degree of initiative and self-motivation.

- Ability to manage multiple priorities successfully.

- Team-oriented, with a focus on achieving team goals.

- Ability to learn quickly, be organized and detail oriented.

- Strong presentation and public speaking skills.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.