Manufacturing & Production

AbbVie

2027 Packaging Co-Op (July - Dec)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

As an AbbVie Packaging Engineering Co-Op, you’ll participate in a paid, six-month program working on meaningful assignments that have a real impact on our business and patients worldwide. AbbVie’s Global Packaging organization offers you an opportunity to work in a variety of packaging formats and materials. Throughout the duration, there will be developmental and networking activities, along with housing and shuttle services for eligible students. Co-op’s will be expected to work from our North Chicago campus headquartered in north suburban Chicago, at least three days per week, in accordance with company policy.

**Key Responsibilities Include:**

- Packaging development and testing for new projects
- Test protocol and test execution
- Material identification, selection, and specifications
- Data mining for standardization opportunities
- Sustainability and packaging improvement opportunities
- Coordinate and perform independent and team experiments in laboratory and manufacturing plants

Qualifications

**Qualifications**

- Currently enrolled in university, pursuing a Bachelor’s in Packaging or related field
- Must be returning to university the semester following your Co-Op
- Expected graduation date between December 2027 - June 2029

**Preferred Qualifications**

- Excellent problem-solving, written, and verbal skills
- Exceptional interpersonal, leadership and project management skills
- Proven track record of teamwork, adaptability, innovation, initiative and integrity
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.)
- Strong academic performance

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Amgen

Mfg Systems Engineer (DeltaV)

**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.

**Manufacturing Systems Engineer**

**What you will do**

Lets do this! Lets change the world! Amgen is seeking an Automation Engineer, internally known as a Manufacturing Systems Engineer, in our state-of-the-art Rhode Island facility to join the Automation Engineering team and who will report to the Mfg Systems Engineering Manager. In this vital role you will support complex and challenging process automation initiatives that require understanding of analytical problem-solving techniques, project management, lifecycle management and Operational Excellence. Additionally, the person is responsible for providing project leadership and daily operational support to the Automation Engineering team at the Amgen Rhode Island site.

Key Responsibilities Include:

- Provides technical support to commercial manufacturing, specific to process control, automation infrastructure, and process systems
- Works closely with multiple teams, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to manage a diverse portfolio of projects
- Leads and supports technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems mainly rooted in DeltaV
- Supports new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs
- Devises new approaches to complex problems through adaptations and modifications of standard automation technical principles
- Develop, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity
- Communicates with multiple levels within the organization, highlighting issues and proposing solutions
- Supports capital project design review, commissioning, and qualification
- Applies automation engineering principles in the design, specification, construction, startup, and validation of process and GMP utilities equipment and systems for an array of projects of significant scope and complexity
- Provides technical support and issue resolution 24x7 on-call support of Automation systems on a rotational based frequency
- Applies experience and knowledge of industry best practices and tools to attain an innovative organization

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The automation engineering professional we seek is a dedicated teammate with these qualifications.

**Basic Qualifications:**

- High school diploma / GED and 8 years of automation and/or engineering experience OR
- Associates degree and 6 years of automation and/or engineering experience OR
- Bachelors degree and 2 years of automation and/or engineering experience OR
- Masters degree

**Preferred Qualifications:**

- Bachelors Degree related technical field
- 3+ years experience in Process Automation Engineering in a manufacturing support environment with at least 1+ year experience in the Pharmaceutical or Biotechnology industries
- 3+ years combined experience with the following product platforms: Emerson DeltaV DCS systems
- Familiarity with industry standards for batch control systems, software development life cycle methodologies, S88, 21 CFR Part 11, Validation, and GAMP
- Strong control system automation background. Design, installation, programming and validation of automated processes
- Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services and non-GMP Utilities preferred
- Experience with Tech Transfer, Process Design, and Commissioning
- Experience with validation and change control methodology

**What you can expect from 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, including remote and hybrid work arrangements, where possible

**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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Rhode Island

Undergrad Co-op DSTS Chemical Engineering - (January June 2027)

**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.

**Undergrad Co-op Drug Substance Technologies Synthetics Chemical Engineering - (January June 2027)**

**What You Will Do**

Lets do this. Lets change the world. During this program, you will use synthetic organic chemistry and chemical engineering principles to deliver robust processes and technologies for the manufacture of Active Pharmaceutical Ingredients (APIs) from early- to late-stage development, and serve our R&D, Clinical and Commercial partners. The Drug Substance Technologies Synthetics organization is principally concerned with translating developmental processes into commercial manufacturing reality through scientific expertise, innovative engineering, and deployment of manufacturing technologies.

The department at our Cambridge, Massachusetts location is looking for an Undergraduate student interested in a 6-month Co-op placement. The Co-op will learn the principles of process scale-up of small-molecule intermediates and active pharmaceutical ingredients using synthetic organic chemistry and chemical engineering principles. The Co-op will have an opportunity to interact with scientists and engineers implementing advanced manufacturing technologies for multiple product modalities. Relocation in the form of a transportation allowance will be provided for eligible candidates.

Program Eligibility Requirements

- Expected completion of one year of study from an accredited college or university prior to the co-op commencing
- Expected continued enrollment in an accredited college or university following the co-op program
- Student must be located in the United States for the duration of the co-op program
- Must be available to work a full-time schedule.

**What We Expect of You**

We are all different, yet we all use our unique contributions to serve patients. The passionate and driven individual weseekexemplifies the following qualifications:

**Basic Qualifications:**

Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria:

- 18 years or older
- Currently enrolled in a full-time Bachelors Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent

**Preferred Qualifications**

- Degree concentration(s) in Chemical Engineering, Chemistry and/or Data Sciences, with a focus or interest in organic synthesis and chemical engineering.
- Strong interpersonal, project management, analytical and quantitative skills
- Strong communication, interpersonal, organizational, project management, problem solving, analytical and quantitative skills
- Demonstrated personal initiative, self-motivation, flexibility, adaptability, and resourcefulness.
- Having experience in one of the listing areas below will be a plus: hands-on experience in the laboratory, flow chemistry, biocatalysis, lab automation, data analysis using Python.

**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 base pay range for this opportunity in the U.S. is $28.87 per hour.

- Build a network of colleagues that will endure and grow throughout your time with us and beyond.
- Bring your authentic self to the table and become the professional youre inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
- Participate in executive and social networking events, as well as community volunteer projects.

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

**careers.amgen.com** Please search for Keyword R-255684

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**

Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles 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

ProcessEngineer- CIP/ SIP/ Autoclave

**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. 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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**ProcessEngineer- CIP/ SIP/ Autoclave**

**What youwill do:**

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise tosupport operations upon start-up.

Site design, construction, start-up, and operational readiness:

Support the commissioning and qualification ofmanufacturingsystems in alignment with GMP requirements and interact with regulatory inspectors.

- Demonstrate technical expertise and provide lifecycle support for CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and associated automation platforms. The role will support commissioning, qualification, startup readiness, routine manufacturing operations, troubleshooting, and continuous improvement initiatives with a focus on CIP, SIP and autoclave systems.
- Ensuresystemsare installed andoperatesafelyandcomply withpertinent environmental health/safetypractice,rulesand regulations.
- Interact with regulatory inspectorsas a manufacturing systems owner to communicate anddemonstrateappropriate regulatorycomplianceofoperating systems.
- Assistwithnew product/technology introductions by performing engineering assessments,implementing equipment modifications, and supporting engineering runs.

**Site Operations:**

- Provide systemsupportforbiopharmaceutical process equipment specifically CIP/SIP and/or autoclave systems.Assistinidentifyingand implementing engineering-based improvements or upgrades to equipment or facility systems.
- Experience with CIP circuit design/validation and SIP
- Support the developmentofbusiness cases for improvements,identification ofdesign requirements, and translation ofthese requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation ofimprovements.
- Develop equipment maintenance programs, ensure the availability of spare parts, andcoordinatemaintenance activities to ensure systems are in proper working order.

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

**Basic Qualifications:**

Masters degree

OR

Bachelorsdegree and 2 years ofEngineeringexperience

OR

Associatesdegree and 6 years ofEngineeringexperience

OR

High school diploma / GED and 8 years ofEngineeringexperience

**Preferred Qualifications:**

- Bachelors degree in Chemical or Mechanical Engineeringor similarengineerdiscipline.

- 3+years'of relevant work experience with2+ years' experience in Biopharmaceuticaloperations/manufacturing environment

- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.

- Ability to analyze problems, develop and propose engineering solutions in a scientificmanner using data-driven techniques and analyses (e.g., Data Analytics, Root CauseAnalysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

- Experience working in a regulated environment (e.g.cGMP, OSHA, EPA, etc.) andfamiliarity with GMP quality systems/processes such as change control, non-conformances,corrective and preventative actions, and qualifications/validation

- Experience applying engineering principles to the design and implementation of systemmodifications, introduction of new processes, and the oversight of capital projects

- Understanding of capital projects in a GMP Biopharmaceutical Production facility includingprocurement, construction, startup, and validation

- Understanding ofsafety requirements working in a GMP Biopharmaceutical Productionfacility.

- Independent, ambitious, organized, able to multi-task in project environments, and skilled incommunication, facilitation, and teamwork

- Collaborativeteammateprepared to work in and embrace ateam basedenvironment thatrelies on communication for effective decision-making

- Strong leadership, technical writing, and communication/presentation skills

- Work schedule flexibility asrequiredto support 24/7 operations, requiring occasionalafterhoursengineering coverage

- Ability for domestic/international travel.

**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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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.

North Carolina

Dyne Therapeutics

Executive Director, TechOps Alliance and Strategic Partnerships

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Executive Director, TechOps Alliance and Strategic Partnerships shapes and leads the strategy, governance, and performance of key external partnerships that enable successful manufacturing, technical operations, development, and supply activities. This role serves as a senior enterprise partner, aligning internal and external stakeholders, anticipating risks and opportunities, and establishing the operating mechanisms required to deliver commitments across the product lifecycle. The role applies deep alliance-management and biopharmaceutical expertise to strengthen partner accountability, support informed executive decisions, and advance Dyne’s strategic and operational objectives.

This position is based in Waltham, MA but open to remote with onsite visits required periodically.

**Primary Responsibilities Include:**

*Alliance Strategy and Governance*

- Shape and lead the TechOps alliance and strategic partnership strategy in alignment with Dyne’s functional and company priorities.
- Establish and evolve fit-for-purpose governance models, decision rights, committees, escalation pathways, operating plans, and performance standards for key partnerships.
- Serve as the primary strategic point of contact for partner organizations and build trusted relationships with senior internal and external stakeholders.
- Guide partnership planning across Manufacturing, Technical Development, Supply Chain, Quality, Development, and other relevant functions to ensure shared priorities and coordinated execution.

*Portfolio Execution and Performance*

- Direct cross-functional planning and execution across partnered manufacturing, technical operations, development, and supply activities, ensuring clear ownership, milestones, dependencies, and deliverables.
- Define and monitor partnership objectives, metrics, budgets, contractual commitments, and business outcomes; identify trends and implement corrective actions when performance is off track.
- Integrate partner plans with internal development and commercialization strategies, including late-stage and launch-readiness priorities.
- Drive disciplined issue resolution and decision-making across complex, ambiguous, and high-impact operational challenges.

*Risk, Communication, and Executive Visibility*

- Anticipate strategic, operational, supply, quality, financial, and relationship risks; lead mitigation planning and escalate critical issues with clear options and recommendations.
- Establish transparent communication pathways that enhance visibility, accountability, and timely decision-making across Dyne and partner organizations.
- Provide concise, decision-oriented updates and recommendations on alliance health, milestone delivery, risks, opportunities, and resource needs to executive leadership.

*Leadership and Organizational Impact*

- Influence enterprise-wide priorities and foster alignment across functions, geographies, and partner organizations without relying on formal authority.
- Champion alliance management best practices, scalable processes, and continuous improvement across TechOps and Dyne.
- Model inclusive, accountable, and collaborative leadership while navigating sensitive negotiations and competing stakeholder perspectives.

**Experience and Skills Requirements:**

- Bachelor’s degree in a relevant discipline required; advanced degree such as an MS, MBA, or PhD preferred.
- 18+ years of relevant pharmaceutical or biotechnology industry experience, or equivalent, including substantial leadership of people, programs, partnerships, or a function; experience at the prior leadership level is preferred.
- 10+ years of management or functional leadership experience, including 5+ years in alliance management within Manufacturing, Supply Chain, Technical Operations, or a closely related area.
- Deep expertise in alliance governance, strategic partnership development, performance management, and execution through external organizations.
- Demonstrated success leading complex, cross-functional initiatives and multiple concurrent workstreams in a matrixed environment.
- Strong knowledge of biopharmaceutical development from late-stage development through commercialization, including manufacturing, technical development, supply, and launch-readiness interdependencies.
- Expertise in strategic planning, governance, contract and milestone oversight, budget management, risk management, and issue escalation.
- Exceptional executive communication, negotiation, influence, relationship-building, and problem-solving skills with the ability to align diverse stakeholders and make sound decisions in ambiguous situations.

\#LI-Onsite

MA Pay Range

$260,000 - $305,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Civica Rx

Principal Engineer: Clean Utilities and HVAC (920)

**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 Purpose**

The Principal Engineer: Utilities & HVAC is the site Subject Matter Expert (SME) for GMP HVAC and Critical Utility systems (WFI, Clean Steam, Process Compressed Air, and Nitrogen) and the ancillary support systems. This role will have specific responsibility in the final project phase of construction at our new site and after project start-up for site day-to-day operation.

This role will be responsible for reliable and cost-effective operation of the site's HVAC, Utilities, and ancillary systems associated with our new manufacturing facility in Petersburg, VA. It will be essential to maintain all these systems in a state of compliance, safety, control, and fit for use. This role will also drive continuous improvement initiatives and local capital investment.

**Major Accountabilities**

- SME with a deep technical expertise in all systems under his/her responsibility (GMP HVAC, GMP Utilities and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, well versed with flow charts and process parameters, and awareness of industry trends.
- Ensure the assigned processes are in alignment with the applicable regulatory Industry and Civica Standards.
- Support risk assessment exercises using the different tools available (eg.FMEA) and participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals.
- Lead or participate in projects/changes for all the systems under his/her responsibility including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
- Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state.
- Monitor utility systems and maintain KPI's to assure that they are operating properly, in compliance with requirements.
- Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters.
- Implement efficient and effective maintenance and reliability techniques.
- Apply problem solving skills by leading equipment failures, troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues.
- Provide customer consultation and notifications on issues that involve utilities areas. Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date.
- Provide technical assistance as necessary to maintenance, and operations personnel.
- Support internal and external inspections and investigations (including Quality and HSE).
- Maintain efficient communications with appropriate site customer groups.
- Proficiency with the DMS and CAPA systems.
- Maintain, develop, and conduct operations training of utility systems.
- Utilize statistical analysis tools to determine the process control, and capability for investigations.
- Participate in Process Hazard Review meetings and/or Safety Teams as required by leadership

**Education/Experience**

- Bachelor’s degree in engineering or relevant sciences and 6+ years of experience with GMP Utilities
- 5 years’ experience with sterile injectables, combo-devices, or biologics.
- Start-up experience preferred.
- Advanced degrees or certification relevant to the role is a plus.
- Ability to think strategically and tactically (detail-oriented).
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.
- Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.

Virginia

Packaging Engineer II (964)

**POSITION SUMMARY**

The Packaging Process Engineer II will function as an integral part in the creation of pen assembly and packaging operations at Civica's first fill-finish manufacturing facility dedicated to the manufacture and supply of essential generic sterile injectable medications in Petersburg, Virginia.

Key duties include coordinating equipment vendor activities through design, fabrication, installation, qualification and serving as front-line technical support to Manufacturing. Responsible for pen assembly, packaging equipment, and line-level serialization systems. The successful candidate will routinely interface with Manufacturing, Quality, Supply Chain, and other internal functions as well as outside suppliers.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**

• Management of equipment vendors including the execution of FAT & SAT, on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.

• Complete FAT, SAT, Commissioning and Engineering Studies.

• Support Validation activities such as IQ, OQ, and PQ.

• Prepare the required cGMP documentation to support production operations.

• Coordinate technical deliverables across all business functions to support successful processes and product launches.

• Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.

• Ability to quickly adapt and adjust priorities in response to unforeseen disruptions in operations.

• Manage changes for responsible equipment as per site change control procedures.

• Participate in regulatory inspections (e.g. FDA, DEA audits).

• Lead improvement of equipment reliability through CI and TPM processes to support the transition from project level to sustainable manufacturing/ramp up production.

**MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)**

• Exposure to pharmaceutical manufacturing and operations including pen assembly, packaging equipment, and line-level serialization systems preferred.

• Strong interpersonal and communication skills, both written and verbal.

• Ability to quickly adapt and adjust priorities.

• Project management experience.

• Ability to work effectively with outside suppliers.

• Knowledge of Lean/Six Sigma methodologies.

• Strong problem-solving skills.

• Strong mechanical aptitude and hands-on approach.

• Familiarity with engineering and architectural/construction drawings is highly advantageous.

• Demonstrated ability and willingness to accept ownership of new technical challenges and assigned projects.

• Passion for Civica's mission to provide affordable quality generic medicines that are accessible to all.

**EDUCATION AND EXPERIENCE**

• 5+ years of experience within the discipline is required.

• B.S. in Engineering or Science discipline required.

• Experience working in a cGMP environment preferred.

• Ability to manage teams to execute activities on the manufacturing floor.

• Experience in a data-driven approach to root cause analysis and prioritization of continuous improvement initiatives (e.g., Six Sigma, 5-why, fishbone diagram).

• Ability to adapt to changing priorities as project demands and business needs change.

• CQV experience and greenfield facility start-up experience preferred.

• Ability to explain complex technical issues to external customers/agencies.

• Demonstrated excellence in planning and organizational skills.

**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 made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands or fingers and handle or feel 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 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.

Aspen Neuroscience

Materials Management Associate

Make an impact behind the scenes where it matters most. As a **Materials Management Associate**, you'll be responsible for maintaining inventory accuracy, supporting manufacturing and laboratory operations, and ensuring materials move efficiently through the organization. This role offers autonomy, visibility, and the opportunity to become a trusted resource in inventory control and warehouse operations while helping maintain audit readiness and regulatory compliance. Join a team that values precision, accountability, and operational excellence. 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:**

- Receive, inspect, and distribute materials, packages, and supplies across multiple facilities and buildings.
- Safely handle, receive, and store hazardous materials in accordance with applicable regulations and procedures.
- Complete required documentation to support material receipt and inspection processes.
- Label incoming materials accurately and maintain material traceability.
- Perform inventory transactions accurately within the inventory control systems.
- Maintain accurate GMP documentation and current records for material receipt, storage, and issuance activities.
- Verify incoming materials against specifications and supporting documentation.
- Maintain inventory accuracy and compliance with FEFO/FIFO inventory management practices.
- Prepare, package, and process domestic and international shipments.
- Support cold-chain and temperature-controlled storage and shipping activities.
- Maintain a clean, organized, and inspection-ready warehouse environment.
- Follow established procedures and complete required training for assigned warehouse operations.
- Actively support and promote 5S and continuous improvement initiatives throughout warehouse operations.
- Operate warehouse equipment and company vehicles safely and in accordance with training and authorization requirements.

**EDUCATION AND EXPERIENCE:**

- High School Diploma or GED required.
- Associate degree in Supply Chain, Logistics, Business, or related field preferred.
- Minimum 2 years of experience in warehouse operations, inventory control, shipping/receiving, or materials management.
- Experience in a GMP-regulated pharmaceutical, biotech, or medical device environment preferred.
- Experience using ERP systems (NetSuite, SAP, Oracle, or equivalent) preferred.

**JOB SPECIFICATIONS:**

- **Organization:**  Strong organizational skills with experience supporting inventory control and warehouse operations.
- **Material Handling:**  Knowledge of FEFO/FIFO material issuing, physical security of materials, and product flow in and out of the warehouse.
- **Compliance:**  Familiarity with cGMP requirements and 5S principles in a regulated environment.
- **Mathematical Aptitude:**  Ability to perform basic calculations and reconcile inventory accurately.
- **Attention to Detail:**  Strong attention to detail with the ability to maintain accurate records and inventory transactions.
- **Computer Proficiency:**  Proficient in Microsoft Office and inventory or receiving systems.
- **Communication:**  Effective verbal and written communication skills with the ability to collaborate across functions.
- **Safety & Hazardous Materials:**  Knowledge of safe material handling practices; experience with hazardous materials preferred.
- **Shipping & Distribution:**  Knowledge of domestic and international shipping processes, including cold-chain and temperature-controlled logistics.
- **Equipment Operation:**  Ability to obtain and maintain forklift certification, as required.
- **Driving Requirements:**  Valid driver's license and ability to safely operate company vehicles between facilities, as required

**WORKING CONDITIONS**

Warehouse, Manufacturing, Office, and Lab environment. While performing the duties of this Job, the employee is frequently exposed to toxic or caustic chemicals. This position requires interaction with manufacturing, quality, facilities, and supply chain personnel. This position will require working in and out of temperature-controlled storage areas. This position will require supporting off-hours or weekend activities as business needs dictate.

No Cleanroom access needed

**PHYSICAL DEMANDS**

While performing the duties of this Job, the employee is regularly required to stand, stand,

walk, sit, move, and lift at least 80% of the time; using 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 70 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

The physical demands and environmental characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

**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 $26.83 - $32.80 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.

California

Intellia Therapeutics

Associate Director, HCP Personal Promotion

**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.

The Associate Director, HCP Personal Promotion will develop and drive the strategy,planningand execution of healthcare provider(HCP)personal promotion activities in support of the successful commercialization of Intellia's gene editing therapy for HAE.

Thisis a criticalrole within the Commercial organization, responsible for building and executing a best-in-class personal promotion model across field channels in preparation for theanticipatedlaunch of the first ever in-vivo gene editing therapy.

**Duties/Responsibilities**

- Lead the development and implementation ofatactical marketing plan to create a differentiated brand experience,with a focus onpersonal promotion, that drives HCP engagement and rapid product uptake

- Oversee the development of all HCPpersonal promotion materials, ensuringconsistency andalignment with brand identity and brand messaging. Ensure that all materialsarereviewedand approvedby CMLR

- Define and developHCP Peer-to-Peer strategy andexecution,lead development ofprogram content and speaker training

- Leaddevelopment ofCommercialHCP Congress strategyincludingsponsorship and booth strategy, partner closely with Marketing Operationsoncongressexecution.

- Collaborate with Field Training in development of sales trainingplantodeliver on brandobjectivesandsuccessfully train on field resources,deliver and supporttrainingas needed

- Partner with theDigital Marketing Leadondigital efforts to engage and educate HCPswith an emphasis ondefiningandoptimizingrep-led communications(e.g.rep-triggered email)

- Oversee the direction and deliverables of multiple priorities, ensuring internal stakeholder alignment across agency partners and cross-functional partners

- Manage external agency partners, ensuringtimelyand budget-conscious execution of marketing initiatives

- Perform other duties as assigned

**Supervisory Responsibilities**

N/A

**Requirements**

**Skills/Abilities**

- Demonstratedstrong working partnerships with cross-functional teams including Medical, Market Access, Patient Services, Commercial Operations, Legal, Regulatory, IT, and external agencies

- Proventrack recordof collaboration and coordination with key internal and external stakeholders, including the ability to influence without formal authority

- Strong scientific/medical aptitude, communicates complex scientific/medical concepts clearly and concisely

- Self-starterwith excellent organizational skills, able to prioritize workload andmaintainhigh attention to detail

- Exceptional communication and presentation skills;ability to articulate a point of view succinctly and effectively to senior leaders and external customers

- Ability to analyze data andidentifyinsights to create compelling messages

- Experience managing complex projects through the Promotional Review Committee processto approval

- A proventrack recordof accountability and delivering results

- Ability to work in a fast-paced, dynamic environment

- Proficiencyin Microsoft Office tools (Excel, Outlook, Word, PowerPoint, etc.)

- Travel as needed: 20%

**Education / Certifications**

- Bachelor’s degreerequired;MBA preferred.

**Experience**

- 8+ years of total experience desired with 5+ years ofbroadbiopharmaceutical industry experience required, with at least2years of dedicated experience within US marketing

- Strongtrack recordin developingHCP speaker programs/peer-to-peer strategies

- Experience in competitive rare/specialty markets isrequired

- Prior US launch experience isrequired

\#LI-KO1

**_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 $187,285.00 - $228,903.00 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/>).

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.

**Sr Engineer**

**What you will do**

Lets do this. Lets change the world. In this vital role you will join the Packaging Engineering group within Combination Product Operations supporting Amgens global packaging network. This Senior Engineer role is designed for engineers from a range of technical disciplines, including packaging, mechanical, material science, chemical, manufacturing, process, systems, industrial, and biomedical engineering. You will be accountable for reliable delivery of technical work within defined projects, systems, or components while applying engineering fundamentals, scientific thinking, and regulated operations experience to develop, implement, maintain, and improve Packaging platforms, packaging configurations, processes, and related lifecycle activities. You will contribute to execution and coordination across teams, make sound technical decisions within established direction and standards, identify risks within your scope, and help ensure work progresses effectively within established plans.

- Own technical deliverables for assigned projects, components, systems, or platform areas, ensuring work is completed with consistent quality, reliability, and compliance.
- Develop, implement, maintain, and improve Packaging platforms that support product supply, technology transfers, and lifecycle management.
- Evaluate, recommend, qualify, and sustain packaging components, materials, processes, and platform elements for pharmaceutical products.
- Apply sound engineering judgment and scientific principles within established standards to solve moderately complex technical problems involving materials, product presentations, equipment, automated processes, documentation, and manufacturing interfaces.
- Identify technical risks, gaps, and issues within scope; anticipate downstream impacts; drive timely resolution; and escalate appropriately with context and potential solutions.
- Lead or support technical assessments, test protocols, qualification activities, engineering reports, specifications, procedures, and change controls.
- Support technology transfers from clinical to commercial and site to site for packaging configurations, equipment, and processes.
- Partner with Product Development, Operations, Manufacturing, Quality, Regulatory, Supply Chain, and other functions to deliver robust, compliant, and scalable packaging solutions.
- Establish priorities, manage project plans and dashboards, communicate progress and issues clearly, and drive work to completion within expected timelines.
- Identify and implement incremental improvements to processes, designs, tools, documentation, or ways of working within defined scope.
- Share knowledge, support team problem-solving, and provide guidance to junior engineers when needed.
- Ensure cGMP, regulatory, and change control expectations are met, and support regulatory inspections or related activities as needed.

**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 leader 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 of**Engineering** experience

OR

High school diploma / GED and 10 years of **Engineering** experience

**Preferred Qualifications:**

- Experience in packaging engineering, manufacturing engineering, process engineering, product development, device or combination product development, clinical supply, or regulated technical operations.
- Experience developing, implementing, maintaining, or improving clinical or commercial packaging configurations, equipment, processes, or lifecycle management programs.
- Experience supporting technology transfers, new product introductions, site start-ups, platform standardization, automated equipment implementation, or process improvements.
- Knowledge of cGMP expectations, change control, qualification, validation, technical writing, and regulated manufacturing environments.
- Demonstrated ability to own technical deliverables, deliver consistent high-quality work, identify and address risks within scope, and escalate issues appropriately with recommended solutions.
- Ability to collaborate effectively with cross-functional partners, communicate technical progress and issues clearly, and contribute constructively to team discussions and alignment.
- Demonstrated ability to identify incremental improvement opportunities in processes, designs, tools, documentation, or ways of working.
- Strong project management, communication, collaboration, technical writing, and technical problem-solving skills.

**What you can expect from 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Senior Engineer - Complaints Technical Investigations

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-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 Engineer - Complaints Technical Investigations**

**What you will do**

Lets do this! Lets change the world! Amgen is currently seeking a Sr. Engineer - Complaints Technical Investigator in our Complaints Technical Investigations group. In support of Amgens mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The Sr. Engineer - Complaints Technical Investigator conducts technical investigations of Advanced complaints associated with product design and/or usability issues and conducts trend and consolidated investigations using data analytics and root cause investigation methodologies. This role understands customer/ patient use of Amgens packaged and/or distributed products, as well as manufacturing processes for these products. The Sr. Engineer - Complaints Technical Investigator owns CAPAs based on root cause and will also participate in multi-functional ideation of design solutions. Also maintains close interaction with the engineering and quality functions to contribute to product improvement. Responsibilities also include complaint sample evaluations, investigation plans, and personnel training.

**JOB RESPONSIBILITIES:**

- Lead root cause analysis to identify the failure mode for Amgens products and associated components due to product complaint
- Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, 5 Whys, risk assessments such as FMEAs, Fault Tree Analysis, or tolerance analysis.
- Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation
- Perform technical trends and consolidated investigations, including statistical assessment of data to identify trends
- Support the evaluation of returned products, product reserve sample inspections, batch records and review of complaint history and trends
- Generate final investigation reports in accordance with established procedures, which may include data collection and statistical analysis of the data
- Develop and perform relational data analytics in support of investigations
- Advise management for trend and failure investigation process improvement
- Provide input to engineering for product improvements
- Manage, coach and mentor staff
- Support functional management initiatives and objectives

**What we expect of you**

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

**Basic Qualifications:**

- Doctorate degree *OR*
- Masters degree and 2 years of operations experience *OR*
- Bachelors degree and 4 years of operations experience *OR*
- Associates degree and 8 years of operations experience OR
- High school diploma / GED and 10 years ofoperations experience

**Preferred Qualifications:**

- Advanced Degree in Science
- 10+ years of progressive and relevant experience
- 5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
- Proven experience with medical devices
- Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
- Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
- Experience with protocol and report writing, process and test development and execution, and design of experiments
- Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
- Strong technical writing and interpersonal skills

**What you can expect from 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 anticipates accepting applications until August 19, 2026; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Senior Manager Packaging 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.

**What you will do**

Lets do this. Lets change the world! In this vital role you will report to the Director of Commercial Secondary Packaging and be based in Ohio, leading a team of engineers responsible for supporting commercial secondary packaging operations for final and WIP product presentations. This role is focused on ensuring reliable, compliant, and efficient packaging processes to meet ongoing commercial supply demands.

The Senior Manager will set priorities and direction for the packaging organization to support day-to-day manufacturing, drive operational excellence, and continuously improve packaging performance across commercial operations. You will collaborate closely with site functions including Manufacturing, Quality, Supply Chain, and Maintenance to ensure consistent delivery of high-quality product to patients.

**Specific responsibilities include but are not limited to:**

- Lead and develop a team of packaging engineers supporting commercial operations, ensuring timely resolution of production issues.
- Drive troubleshooting and root cause analysis for deviations, implementing effective CAPAs.
- Improve packaging line performance through enhanced equipment reliability, process robustness, and operational efficiency.
- Own packaging configurations, specifications, and maintenance of the qualified state for commercial products.
- Partner with Manufacturing, Quality, and **External Supply** to ensure compliance with regulatory requirements and inspection readiness.
- Lead continuous improvement initiatives to reduce downtime, waste, and process variability.
- Support change control activities, including packaging updates, material changes, and process improvements across internal and external sites.
- Provide regular updates to site leadership on performance, key issues, and improvement efforts.
- Collaborate with cross-functional, network, and **external partners** to align on standards and share best practices.
- Manage resources and priorities to meet production schedules and business needs.
- Provide technical oversight to external partners and suppliers supporting packaging operations.

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

OR

Masters degree and 6 years of Engineering, Materials Science, or Industrial Design experience

OR

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

OR

Associates degree and 10 years of Engineering, Materials Science, or Industrial Design experience

OR

High school diploma / GED and 12 years of Engineering, Materials Science, or Industrial Design 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

**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

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.

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.

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.

Instrumentation Technician (Various Shifts: Days, Swing, Grave)

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.

**Instrumentation Technician**

**What you will do**

Lets do this. Lets change the world. We are all different, yet we all use our unique contributions to serve patients. The technical professional weseekis a collaborative and motivated team player with the following qualifications.

Within the Facilities & Engineering team, you will:

- Perform scheduled calibration, corrective maintenance, installation, repair, and troubleshooting of instruments and equipment used in process control systems and building systems across the site.
- Complete quality and safety documentation while performing work in a safe, compliant, andtimelymanner according to predefined schedules and in alignment with GMPs, SOPs, and Amgen policies.
- Troubleshoot and repair equipment and systems as needed.
- Ensure work activities are communicated effectively to system operators and key stakeholders.
- Ensure work order documentation is completed accurately and completely in the maintenance management system.
- Work in a highly productive and efficient manner to maximize maintenance activities while minimizing impacttoproduction.
- Review or contribute tomaintenance ofreports, forms, plans, and records asrequired.
- Identifywaste, workflow interruptions, and opportunities for improvement; recommend solutions andassistwith implementation.
- Activelyparticipatein training and development to build new technical skills and improve overall team performance.
- Represent the maintenance team in cross-functional discussions and meetings whenrequired.
- Provide facility and manufacturing support including participation in on-call rotations or shifts outside normal working hours (nights, weekends, or holidays) as needed.
- Available to workthe various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) or as needed.

**Additional Required Skills:**

- Good organizational skills and the ability to read and understand technical documentation such as operating manuals and engineering drawings.
- Ability to stand or sit for extended periods of time andlift up to 35 pounds.
- Ability to work independently with minimal direction and communicate task status effectively.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The technical professional weseekis a collaborative and motivated team player with the following qualifications.

**Basic Qualifications:**

- High school/GED + 1 yearof maintenance, operations, manufacturing work experience or military experience OR
- Associate's degree

**Preferred Qualifications:**

- Experience with**instrumentation, calibration, and metrology programs**.
- Experience in mechanical maintenance with emphasis on**sanitary processing equipment and systems**.
- Knowledge of**pneumatic, hydraulic, and mechanical systems**.
- Experience working ina**cGMPregulated environment**.
- Experience documenting work orders in a**computerized maintenance management system (CMMS)** .
- Ability to interpret**P&IDs and technical diagrams**.
- Technical school training with hands-on experience in operations, manufacturing, or maintenance.
- Strong computer and communication skills.
- Ability to collaborate effectively with cross-functional teams andprovidetechnical guidance when needed.

**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.

Director EHSS

**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. 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.

Be part of Amgens next generation drug substance manufacturing facility in North Carolina. We are starting up our first facility and breaking ground on our second facility. Both facilities feature the best in-class drug substance technologies and integrate sustainability innovations to reduce carbon and waste, as part of Amgens plan to be a carbon-neutral company by 2027.

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

**Director EHSS**

**What you will do**

Lets do this. Lets change the world. In this vital role, you will be responsible for corporate policies, guidelines, and standards as well as related training programs and regulatory compliance. Provides leadership vital to implement global EH&S programs. Develops, monitors, and coordinates Company EH&SS programs in accordance with federal, state, and local regulations. Initiates and maintains extensive contacts with key managers and officials of other organizations and regulatory agencies, requiring skill in persuasion and negotiation of critical issues. Provides market/customer sensitivity and commits to talent development.

- As a leader of this area, you are responsible for an important segment of the EH&S function with extensive and diversified requirements.
- Provides corporate oversight on matters related to compliance with federal, state, and local regulations.
- Establishes, builds consensus, and communicates standards and guidelines to the organization.
- Conducts periodic audits, surveys, and visits along with established governance systems and keeps management apprised of potential risks and liabilities.
- Focuses on prevention and actively participate in setting the agenda for EH&S as well as the development and revision of regulations affecting Company operations.
- Recommends facilities, staffing, and funds required to carry out programs, which are directly related with and directed toward fulfillment of overall organizational objectives.
- Is a recognized leader and authority in a broad area of EH&S specialization.
- Selects EH&S programs to further the organizations objectives.
- Conceives and plans investigations of broad areas for which precedents are lacking in areas critical to the overall EH&S function.
- Is consulted extensively by associates and others with a high degree of reliance placed on their scientific interpretations and advice.
- Directs several subordinate supervisors or team leaders.
- Responsible for the successful operation of activities. Ensures that overall budgets, schedules, and performance standards are realistically set and attained.
- Provides periodic reports of progress and plans and conducts briefings and technical meetings for senior management as appropriate.
- Ability to prioritize multiple tasks in a fast-paced environment

**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 strong leader with these qualifications.

**Basic Qualifications:**

- Bachelors degree and 10 years of Environmental Health and Safety experience OR
- Masters degree and 8 years of Environmental Health and Safety experience OR
- Doctorate degree and 4 years of Environmental Health and Safety experience OR

And

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources.

**Preferred Qualifications:**

- Educational background in Environmental Science, Applied Science in Occupational Safety, Life Sciences or Engineering
- 5+ years of successful EH&S leadership experience directly managing EH&S staff
- 10+ years of individual contributor experience in EHS (Safety focus)
- Excellent written and verbal communications skills in English and Spanish.
- Successful experience in leading teams in a multi-plant and/or multi-site cGMP-regulated commercial manufacturing environment, including cross-functional team leadership
- Demonstrated knowledge of federal, state, and local EH&S regulatory requirements, industry trends, and ability to work optimally in a globally-matrixes organization and team environment
- Strong leadership, influencing and administrative skills, including financial and project management abilities
- Demonstrated success in communicating technical and administrative topics and matters to different levels of the organization, including operating and executive level staff
- Lean-Six Sigma Green Belt Certification

**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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

**careers.amgen.com**

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

Service Worker

**Service Worker**

Job ID: req4644

Employee Type: nonexempt full-time

Division: Facilities, Maintenance & Engineering

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 Facilities Maintenance and Engineering (FME) Directorate is responsible for laboratory space, administrative space, infrastructure, campus landscape, planning, and design, and construction management at Frederick National Laboratory for Cancer Research.

**KEY ROLES/RESPONSIBILITIES**

- Perform a variety of cleaning duties in laboratory and office areas.
- Ensure all areas are cleaned thoroughly and meet any hygiene requirements.
- Prioritize cleaning tasks to meet deadlines and maintain consistent facility cleanliness.
- Remain flexible in handling varying tasks and/or unexpected challenges.
- Clean and wash windows, woodwork, furniture, floor coverings, fixtures, stairwells, fire doors, and restrooms.
- Vacuum, dust, and wet mop floors.
- Spray, buff, strip, and refinish floors.
- Clean carpets.
- Operate autoclaves.
- Operate industrial power equipment for cleaning.

**BASIC QUALIFICATIONS**

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

- Possession of a high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency.
- No work experience required with a high school diploma.
- Ability to operate industrial power equipment used for cleaning.
- Ability to read and understand written instructions in English, specifically, but not limited to, safety procedures and training, and signage.
- Ability to perform physical duties including - lifting and carrying up to 50 lbs, walking, standing, climbing stairs, bending, stooping, and working in confined areas, potential exposure to particulates, vapors, or noisy environments.
- Ability to wear required Personal Protective Equipment (PPE).
- Demonstrate reliability, punctuality, and a strong work ethic.
- Commitment to providing excellent service and maintaining standards of cleanliness.
- Maintain a cooperative and supportive attitude toward team members and contribute towards a positive workplace culture.
- Present a clean appearance and maintain a respectful demeanor.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

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

- Knowledge of stripping and waxing procedures for hard-surfaced floors.
- Prior experience in janitorial or cleaning services is a plus.

**JOB HAZARDS**

- This position is subject to working with, or having 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>)

33,600.00 - 49,220.00 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

Maryland

Laborer

**Laborer**

Job ID: req4695

Employee Type: nonexempt full-time

Division: Facilities, Maintenance & Engineering

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 Facilities Maintenance and Engineering (FME) Directorate is responsible for laboratory space, administrative space, infrastructure, campus landscape, planning, and design, and construction management at Frederick National Laboratory for Cancer Research.

**KEY ROLES/RESPONSIBILITIES**

Laborer is responsible for loading, transporting, delivering, and setting up heavy equipment, supplies, and facility-related items while operating forklifts, trucks, lifts, tractors, snow-removal equipment, and various hand and power tools. Performs groundskeeping, landscaping, snow and ice removal, facility support, equipment maintenance, and other assigned duties while following safety procedures, maintaining accurate work records, and working effectively in indoor and outdoor environments.

- Load, move, and transport heavy equipment; assist with equipment setup and the handling of industrial, laboratory, and facility-related items.
- Operate forklifts, trucks up to 10,000 GVWR, vertical lifts, jib rigs, snow blowers, garden tractors, utility tractors, and small hand and power tools.
- Transport, deliver, and set up equipment and supplies at onsite and offsite facilities.
- Assemble shelving, office furniture, and related equipment.
- Maneuver and transport materials and equipment weighing in excess of 500 lbs. on a frequent basis with the assistance of forklifts and other material-handling equipment.
- Perform groundskeeping and general landscape maintenance throughout the campus, including mowing, trimming, edging, weeding, leaf and debris removal, and other routine grounds maintenance activities.
- Operate and maintain groundskeeping equipment, including lawn mowers, string trimmers, blowers, garden tractors, utility tractors, and other landscaping tools and equipment.
- Assist with seasonal grounds maintenance, including spring and fall cleanup, removal of leaves and vegetation debris, and maintenance of landscaped and common outdoor areas.
- Maintain sidewalks, walkways, roadways, loading areas, and other exterior spaces by removing debris, vegetation, snow, and ice as required.
- Assist with snow and ice removal operations, including operating snow blowers, tractors, and other snow-removal equipment and applying deicing materials as directed.
- Perform routine inspection, cleaning, and basic care of groundskeeping tools and equipment and report equipment requiring repair or maintenance.
- Perform work indoors and outdoors in varying weather conditions and occasionally in environments that are dusty, noisy, or may contain work hazards.
- Participate in a rotating 24-hour call-in schedule for emergency repairs, snow and ice response, and other facility needs.
- Log delivery and work activity and status digitally and/or by hand as required.
- Communicate effectively and work cooperatively as part of a team.
- Follow established safety procedures when operating vehicles, powered equipment, landscaping equipment, and hand tools.
- Work in areas with the potential for exposure to biological, chemical, animal allergens, and other laboratory-related hazards.
- Perform other operations, maintenance, groundskeeping, and facility support duties as assigned.

**BASIC QUALIFICATIONS**

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

- Possession of a high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency.
- No work experience required with a high school diploma.
- Must have and maintain a valid State Driver's License issued by the state in which the candidate resides. Must have no more than 3 demerit points in the previous twelve (12) months or five (5) demerit points in the preceding thirty-six (36) months as determined by the Leidos Biomed Use of Government Owned or Leased Vehicles Policy.
- Ability to perform physical duties, including manually lifting and carrying up to 50 lbs.
- Ability to perform sustained physical and outdoor work, including walking, standing, climbing stairs, bending, stooping, kneeling, and working in confined areas.
- Ability to work outdoors in varying weather conditions while performing groundskeeping, snow removal, material handling, and other facility maintenance activities.
- Ability to work in an environment with potential exposure to particulates, vapors, noise, and other environmental or workplace hazards.
- Basic computer skills.
- Basic understanding of power hand tools, use and operation.
- This position is considered safety sensitive and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

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

- Experience with groundskeeping, landscaping, lawn care, or general exterior facility maintenance.
- Experience operating lawn mowers, string trimmers, blowers, garden tractors, utility tractors, snow-removal equipment, or similar grounds maintenance equipment.
- Knowledge of safe practices associated with groundskeeping, landscaping, industrial construction, and support equipment.
- One (1) year of forklift experience.
- Experience working for sustained periods performing manual labor indoors and outdoors.
- Experience performing snow and ice removal.
- Awareness of general provisions governing hazardous materials in transportation.

**JOB HAZARDS**

- This position is subject to working with or has the potential for exposure to animals(s) and/or animal material(s).
- This position is subject to working in or have the potential to exposure to high noise levels for extended periods of time required medical clearance.

**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>)

34,400.00 - 60,200.00 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

Sanofi US

B87 Filling and Form Manager 3rd Shift

**Job Title**: B87 Filling and Form Manager - 3rd Shift

**Location:**  Swiftwater, PA

**This is a 3rd shift leadership role with flexible scheduling during startup and qualification phases.**

**About the Job**

This Production Manager B87 Aseptic Filling & Formulation will lead aseptic filling and formulation operations in a new, state-of-the-art facility during a critical startup and qualification phase. You will be responsible for the overall safety, quality, compliance, productivity, and performance of your assigned team as the facility progresses through Development Aseptic Process Simulations (media fills) in Q4 2026 and Process Performance Qualifications (PPQs) in 2027, with a target of full commercial readiness in 2028.

You are a hands-on, forward-thinking leader who brings deep GMP expertise, a digital-first mindset, and the courage to challenge conventional processes. You thrive in dynamic, fast-paced environments and are energized by the opportunity to build something from the ground up. You lead with curiosity, inspire your team to continuously learn and improve, and hold yourself and others accountable to the highest standards.

This role requires a flexible schedule during the startup and qualification phases, with a transition to 3rd shift during commercial operations. C&Q activities will predominantly occur on first shift; media fills, PPQs, and commercial launch activities will require shift-aligned hours as applicable.

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**

- Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through all phases of commissioning, qualification, and commercial readiness
- Drive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026
- Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027
- Apply innovative, analytically driven solutions to complex startup and qualification challenges
- Champion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-making
- Challenge conventional processes and drive continuous improvement across the operation
- Build and develop a high-performing, agile team aligned with company values and culture
- Ensure strict GMP compliance and regulatory readiness at all times
- Work effectively across cross-functional teams in a fast-paced, multi-priority startup environment
- Serve as Subject Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activities

**Startup & Qualification Leadership**

- Lead the operations team through all facility startup, commissioning, and qualification phases
- Drive execution of Environmental Monitoring Performance Qualifications (EMPQs)
- Oversee smoke studies and cleanroom qualification activities
- Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026
- Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectations
- Drive inspection readiness actions to ensure the facility is prepared for regulatory inspection (FDA PAI in 2027)

- Ensure all C&Q activities are executed in compliance with applicable regulatory standards (cGMPs, CBER, WHO, EP, and other governing bodies) Operational Excellence
- Own shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activities
- Drive execution performance using SMS 2.0 standards, routines, and digital tools
- Leverage digital systems including eOOE, iObeya, SAP, Qualipso, and Ocularis to optimize operations, enable real-time decision-making, and maintain operational visibility
- Lead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits
- Lead real-time problem solving in a dynamic, evolving environment
- Support on-time closure of quality items and deviations to meet site performance metrics and product release requirements
- Provide analysis and recommendations to management on quality systems matters
- Participate in cost reduction and efficiency initiatives

**Leadership & Team Development**

- Build, lead, and develop a highly trained operations team from startup through commercial launch
- Foster a culture of learning, innovation, accountability, and challenging the status quo
- Empower team members and ensure accountability at all levels of the organization
- Demonstrate strong interpersonal and coaching behaviors
- Drive cross-functional collaboration and process optimization across the facility and broader M&S organization
- Assist with team development, training, and competency building throughout all phases

**Digital Mindset & Innovation**

- Champion digital transformation initiatives within operations Utilize data analytics and digital tools to drive informed, real-time decision-making
- Identify and implement technology-enabled process improvements
- Lead adoption of Industry 4.0 principles within aseptic operations

- Model a digital-first approach and encourage the team to leverage available technology to its fullest potential

**KEY COMPETENCIES**

- Leadership Presence: Ability to inspire, develop, and hold teams accountable in a startup environment
- Digital-First Mindset: Comfort leveraging technology, data, and digital platforms to drive operational performance
- Intellectual Curiosity: Genuine desire to continuously learn, improve, and explore new approaches
- Courage to Challenge: Willingness to question the status quo and drive meaningful change
- Critical Thinking: Strong analytical and problem-solving capabilities applied to complex qualification and operational challenges
- Proactive Collaboration: Partners cross-functionally with a focus on optimization, efficiency, and shared outcomes
- Communication Excellence: Communicates progress, issues, and resolution actions clearly and accurately across all organizational levels
- Anticipation & Proactivity: Identifies and communicates constraints, conflicts, and risks before they escalate
- Conflict Resolution: Resolves execution roadblocks within sphere of influence; escalates appropriately when needed
- Agility & Adaptability: Thrives in a fast-paced, multi-priority startup environment with evolving demands Accountability & Ownership: Takes full ownership of team performance, quality outcomes, and operational results

**About You**

**Basic Qualifications**

**This is a 3rd shift leadership role with flexible scheduling during startup and qualification phases.**

- Bachelor's degree in Life Sciences, Engineering, or a related field with 1+ years of pharmaceutical/GMP manufacturing operations experience and 6+ months of people leadership experience (formal or demonstrated leadership capability, e.g., team captain, project lead, supervisory role) **OR** High School Diploma with 5+ years of pharmaceutical/GMP manufacturing operations experience and 1+ years of people leadership experience (formal or demonstrated leadership capability, e.g., team captain, project lead, supervisory role)
- Demonstrated experience in aseptic processing operations (Drug Substance, Drug Product, Biologics)
- Strong working knowledge of GMPs and regulatory compliance requirements
- Proven leadership experience with the ability to build, develop, and manage teams
- Excellent technical writing, communication, and interpersonal skills
- Ability to work flexible hours, including extended shifts and weekends, to support qualification activities and production schedules
- Proficiency with digital systems and data analytics tools

**PREFERRED QUALIFICATIONS**

- Experience in facility or production line startup, commissioning, or qualification activities
- Background in media fill execution and aseptic process validation (APS/PPQ)
- People management experience with a demonstrated track record of hiring and developing a new team
- Knowledge of continuous improvement methodologies (Lean, Six Sigma, or equivalent)
- Experience with SMS 2.0 or similar lean manufacturing operating systems
- Familiarity with Industry 4.0 concepts and digital manufacturing tools
- Change management experience in a regulated manufacturing environment
- Ability to influence across functions and organizational levels without direct authority
- Previous experience in biologics, vaccines, or sterile drug product manufacturing

**WHAT WE OFFER**

- A rare opportunity to build operations from the ground up in a state-of-the-art aseptic facility
- A leadership role at the centre of a high-visibility startup and qualification program
- Exposure to cutting-edge aseptic processing technology and next-generation manufacturing practices
- Career development and growth within a dynamic, expanding organization
- A collaborative, innovative work environment that values curiosity, digital thinking, and challenging the status quo

**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 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-SP

\#LI-SP

\#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>)