Engineering

GenScript

Automation Service Engineer

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

The position reports to Automation Engineer and is responsible for technical support for laboratory automation platforms, including troubleshooting and equipment recovery at the Piscataway site of the GenScript Gene R&D department.

**Responsibilities:**

1. Provide daily technical support for laboratory automation platforms, including troubleshooting, problem diagnosis, repair, and equipment recovery.
2. Troubleshoot mechanical, electrical, pneumatic, sensor, robotic, communication, and basic software-related issues.
3. Support automation platforms such as Tecan, Hamilton, and other laboratory automation equipment.
4. Perform routine preventive and corrective maintenance to improve equipment reliability and minimize downtime.
5. Conduct root cause analysis (RCA) for recurring or significant equipment failures and implement corrective actions.
6. Track recurring equipment issues and identify opportunities for reliability and performance improvement.
7. Maintain equipment service history, maintenance records, troubleshooting records, and error information.
8. Build and maintain an Automation Knowledge Base, including common issues, troubleshooting procedures, root causes, corrective actions, recovery procedures, and Lessons Learned.
9. Develop and update SOPs, work instructions, troubleshooting guides, and maintenance procedures to support long-term knowledge transfer.
10. Support equipment installation, commissioning, upgrades, modifications, and small automation improvement projects.
11. Work closely with laboratory users to resolve equipment issues and improve daily automation platform operation.

**Qualifications**

1. Bachelor's degree in Mechanical Engineering, Electrical Engineering, Mechatronics Engineering, Automation Engineering, or a closely related engineering field.
2. 1+ year of relevant engineering experience in equipment support, automation, maintenance, manufacturing, or a related technical environment.
3. Hands-on experience troubleshooting mechanical and/or electrical equipment.
4. Experience reading technical manuals, mechanical drawings, electrical schematics, and wiring diagrams.
5. Ability to perform systematic troubleshooting and root cause analysis.
6. Strong technical documentation and problem-solving skills.

**Preferred Qualifications**

- Experience with laboratory automation systems or automated life-science equipment.
- Hands-on experience with Tecan and/or Hamilton automation platforms.
- Experience with liquid handlers, robotic arms, plate handlers, stackers, barcode scanners, sensors, motors, pneumatics, or similar automation components.
- Experience supporting equipment preventive maintenance and corrective maintenance.
- Experience creating troubleshooting guides, maintenance procedures, SOPs, or technical knowledge bases.
- Basic understanding of equipment communication, networking, TCP/IP, serial communication, or automation software is a plus.
- Basic programming or scripting experience is a plus.
- Experience in a biotechnology, pharmaceutical, laboratory, or regulated manufacturing environment is a plus.

**Benefit:**

- Medical Insurance/ Vision Insurance/ Dental Insurance
- 401(k) & Retirement Savings Plan (RSP)
- Short Term Disability Insurance
- New Child Leave
- Paid Time Off
- Paid Company Holidays per year
- Paid Sick Days (earned based on hours worked)
- Compassionate Leave
- Jury Duty Leave
- Float day
- Personal days

**Compensation:**

Salary range: $60,000 – $80,000, depending on experience and qualification

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

New Jersey

Boston BioProducts

Process Development Associate

As Boston BioProducts continues to grow, we are expanding our Process Development (PD) team and are seeking a Process Development (PD) Associate. This role is instrumental in supporting new product introductions by ensuring products meet customer specifications and quality expectations. The PD Associate will also evaluate the feasibility, scalability, and accuracy of products and processes while driving continuous improvements that enhance efficiency, consistency, and overall quality. As we continue to scale, this position plays an important role in maintaining the high standards our customers expect.

This is a 100% (Mon-Fri) onsite role in Milford, MA - LOCAL CANDIDATES ONLY

\*\*Direct Applicants ONLY - No Staffing Agencies or Third-Party Recruiters.

Responsibilities:

- Calculate, perform, verify and review chemical product formulations
- Onboards new products following BBP procedures and standards (documentation, feasibility, scalability, consistency, and verification)
- Generates manufacturing batch records and translates customer requirements into technical instructions for manufacturing
- Create pilot, verification, and investigational batches
- Assist in performing investigations for complaints, verification or new procedures
- Draft, review and update SOPs, Work Instructions, Memos, Safety Data Sheets, etc.
- Communicate with clients and vendors to ensure timelines and projects are completed.
- Forecast and provide minimum quantities of raw materials, chemicals and consumables.
- Calibrate, qualify, validate, and perform preventative maintenance on equipment
- Review previous processes, SOPs, and procedures for potential improvement
- Training staff in new procedures, equipment usage, lab and chemical safety
- Ensuring that all products are properly discarded in accordance with the Safety Data Sheet
- Work on new projects assigned by Process Development Manager as they arise

Education:

Bachelor's degree in Biology, BioChemistry or any related discipline

Experience:

Minimum of 2-3 years working in a GMP, ISO or manufacturing environment

Knowledge & Skills:

- Includes all Knowledge and Skills of a Process Development Associate I
- Ability to perform calculations for new and existing products
- Ability to meet deadlines, multitask, and change priorities while maintaining productivity
- Ability to coordinate internally and externally with BBP team members and clients to ensure project completion.
- Ability to work well independently and within a team

Physical Requirements:

- Stand and work in a lab environment for an extended period
- Ability to Lift and Transfer up to 25 pounds
- Work underneath a Biological Safety Hood for an extended period

Massachusetts

AbbVie

Senior Systems Engineer – Aesthetic Filler & Combination Products (all genders)(full-time, regular)

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

People. Passion. Possibilities. Three words that make a world of difference.

More than a job. It's a chance to make a real difference.

Welcome to AbbVie! As part of an international company with 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

**Together, we break through –** as **Senior Systems Engineer – Aesthetic Filler & Combination Products (all genders)**

We are looking for a Senior Systems Engineer to join our Device and Combination Product Development team in R&D. You will contribute to the development of exciting new aesthetic devices and therapeutic combination products for various phases of clinical studies and work closely with cross-functional colleagues in operations as programs transition to commercial development.

In this role you’re also responsible for integration of inputs and risks from multiple disciplines to ensure robust patient-centric product design and performance. In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of devices, drug delivery systems from syringes to autoinjectors to complex electromechanical pumps, with a focus on Aesthetic Filler devices. Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use for clinical and commercial development programs.

**Make your mark**

- Drive the implementation of holistic Systems Engineering principles within the Design Controls process, with a focus on system architecture and integration, Design Inputs, traceability, risk management, change management, and DHF architecture.
- Define and manage user and stakeholder needs, use cases, product requirements, and applicable standards throughout the product development lifecycle.
- Lead system and use-related risk management activities, including risk planning and reporting, system risk assessments, and design and process FMEAs.
- Oversee and integrate third-party development activities and ensure alignment of Design Control and Quality by Design activities.
- Collaborate with cross-functional team members to identify process gaps, recommend and implement improvements, and help standardize methods and ways of working to enhance consistency, efficiency, operational effectiveness, and the development of sustainable business and organizational strategies.
- Collaborate with cross-functional teams to plan and coordinate testing activities, including sample and laboratory resource planning, and drive improvements to processes, methods, and ways of working.
- Serve as the dedicated systems engineer for projects, independently owning key deliverables and coordinating stakeholder input as needed to support successful execution.

Qualifications

**This is how you make a difference:**

- Bachelor’s degree in Engineering, Science, or a closely related discipline with 7+ years of relevant experience, or a Master’s degree with 5+ years of relevant experience.
- Proven ability to provide technical leadership, ensuring system design and documentation comply with applicable safety and regulatory requirements.
- Expertise in product development from initial concept to release to market is desired with direct experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred.
- Strong Expertise in Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, and change management
- Expertise in DHF management and creating various Design Control documents in compliance with regulations.
- Strong analytical and problem-solving skills, with the ability to resolve key project challenges, make sound decisions, identify risks, and develop appropriate mitigation plans.
- Experience working with third-party vendors, including vendor communication, management, and deliverable acceptance testing; intercultural competence in a global environment.
- Experience with Aesthetic Filler products is preferred.
- Strong written and verbal communication skills, including scientific writing, combined with a self-driven and structured approach to managing priorities and timelines.
- Excellent written and oral communication skills in Englisch as well as in German with the willingness to travel internationally as required (10–20%).

**What we offer you:**

- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network

At multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email at Talentacquisition.de@abbvie.com – We look forward to hearing from you!

Additional Information

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>)

Other Non-US

IDEAYA Biosciences

Director, CMC Process Chemistry

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA.

Position Summary:

We are seeking an experienced and highly motivated Director, Process Chemistry to join our multidisciplinary team based in South San Francisco. This role requires the candidate to work collaboratively with the related cross-functional teams to support our drug discovery pipeline. The successful candidate will be responsible for but not limited to those responsibilities listed below.

This position is based in our South San Francisco headquarter offices and is required to be onsite four days per week per our company policy.

Reporting to: Senior Director, Head of Process Chemistry

Job Description

**What you’ll do:**

- Lead Process Chemistry efforts in facilitating drug substance (DS) development by managing multiple CDMOs across all stages of drug development (pre-clinical, Phase I – III, and commercial). This position will be responsible for traditional small molecule targets and may also support the scale up of small molecule ADC payload/linkers.
- Author and review technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigations.
- Author and review necessary technical sections in IND/IMPD/NDA documents supporting global CMC regulatory submissions and remain current on Health Authority guidance and expectations.
- Represent DS/CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of DS to support PK/PD, efficacy, DRF and pilot toxicology studies, IND-enabling activities, and clinical trials across a portfolio of programs.
- Collaborate closely in cross-functional teams including but not limited to Medicinal Chemistry, DMPK, Analytical Chemistry, Formulation, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology to achieve project goals.
- Proactively communicate with and work closely with other functions to align DS and CMC strategies to achieve and maintain aggressive timelines to ensure goals are met.
- Lead the evaluation, selection, and management of CDMOs to perform DS development, and GMP manufacture.
- Oversee technology transfer activities at CDMOs to ensure successful manufacturing and provide technical expertise in troubleshooting and resolving issues as necessary.

**Requirements:**

- Ph.D. in Chemistry with a minimum of 10 years (or a M.Sc. with a minimum of 14 years) of chemical process development experience in a pharmaceutical or biotechnology company, and demonstrated ability in leading cross-functional groups. Late phase and commercial experience are a plus.
- Track record of success in delivering timely execution of DS and CMC activities ranging from preclinical, IND-enabling and NDA material supplies and commercialization. Experience in the manufacture of small molecule ADC payload/linkers is desired.
- Strong understanding of Quality systems including SOPs, manufacturing batch record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management.
- Established knowledge and application of current industry standards and regulatory authority guidance and expectations, including ICH, FDA, and EMA guidelines.
- Experience managing global CDMOs, both dedicated FTE teams and FFS projects.
- Exceptional problem-solving skills and ability to quickly adapt and shift focus as needed.
- Excellent interpersonal and communication skills for internal and external collaborations.
- Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic.
- Able to travel domestically and internationally to oversee DS development and manufacturing at CDMOs.

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

**Total Rewards**

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Director, CMC Process Chemistry is $206,000 - $254,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.

California

Sr Engineer, Emerging Device Technology

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

AbbVie’s Device and Combination Product Development and Drug Delivery (DCPD) organization provides the expertise required to develop and advance drug delivery systems supporting AbbVie’s biopharmaceutical portfolio. Within DCPD, the Landscaping & Platform Definition (L&PD) group leads front-end strategy and assessment activities focused on future delivery system needs across the pipeline. The team defines technical and business requirements, evaluates emerging delivery technologies, and conducts feasibility and fit-for-purpose assessments to identify the most viable solution pathways.

The group assesses a broad range of delivery system technologies, including autoinjectors, patch pumps, continuous infusion systems, and connected delivery ecosystems. This work helps ensure AbbVie’s delivery solutions align with pipeline, patient, clinical, and commercial needs while supporting long-term platform and portfolio strategies. As delivery system requirements continue to expand across AbbVie’s pipeline, L&PD is growing its capability to assess, prioritize, and advance technologies with the strongest strategic and technical fit. In addition to supporting individual asset programs, the group also identifies scalable platform opportunities that may serve multiple pipeline applications.

This role is intended for an individual with an understanding of drug delivery systems, familiarity with design control principles, and the ability to apply structured, strategic thinking to technology assessment, opportunity evaluation, and future delivery system definition in support of AbbVie’s therapeutic pipeline.

Overview of Position:

The Device Technology Horizon Engineer will play a key role in evaluating delivery system and device solutions that support AbbVie’s therapeutic pipeline and contribute to improved patient outcomes. This role sits at the intersection of early needs assessment, technology evaluation, and strategic decision support, helping translate evolving therapeutic, clinical, and business needs into clear delivery system strategies and recommendations.

Within the Device and Combination Product Development (DCPD) department and Landscaping & Platform Definition (L&PD) group, this individual will work cross-functionally with CMC, Asset Teams, Commercial, and external partners to identify and assess future delivery system opportunities for pipeline assets in early development. The role includes evaluating emerging technologies, supporting feasibility planning, and helping determine which solutions offer the strongest technical, strategic, and platform potential across AbbVie’s portfolio.

The successful candidate will bring strong critical thinking, a structured approach to complex problem solving, and the ability to operate effectively in evolving and ambiguous environments. They will be organized, adaptable, and capable of translating complex technical and strategic considerations into clear recommendations that align cross-functional stakeholders and support informed decision-making.

Key responsibilities include:

- Identify patient, clinical, and business needs and translate them into delivery system requirements and strategic considerations
- Partner with Product Development Directors, Asset Teams, Commercial teams, and external collaborators to define future delivery system needs for early-stage pipeline assets
- Evaluate a broad range of delivery system technologies and maintain awareness of external technology trends, manufacturers, and emerging capabilities
- Develop and assess technology landscapes to identify and prioritize candidate delivery system solutions
- Compare candidate technologies based on technical feasibility, strategic fit, scalability, and potential portfolio value
- Support down-selection activities to identify the most promising technologies for further feasibility and development efforts
- Define feasibility assessment needs, including evaluation of critical performance attributes and development risks
- Support request for proposal (RFP) development, feasibility planning, budget estimation, and engagement with external partners
- Contribute to development timelines, feasibility strategies, and early-stage planning activities
- Support progression decisions related to feasibility and future development pathways
- Conduct applied research and strategic landscape assessments to inform delivery system direction and platform strategy
- Evaluate opportunities for technologies to serve multiple AbbVie assets as scalable platform solutions
- Distill complex or evolving information into concise recommendations, strategic insights, and actionable next steps
- Apply structured frameworks and practical decision-making approaches to align stakeholders around priorities, opportunities, and tradeoffs
- Communicate effectively across technical, strategic, and commercial functions to drive clarity and alignment
- Operate effectively in a fast-paced environment with evolving priorities, timelines, and inputs

\* This position can also be based out of our South San Francisco, Irvine and Germany Locations \*

Qualifications

- BS, MS, or PhD in Mechanical, Biomedical or related engineering discipline.
- Strong working knowledge of design control and combination product and device development
- 12 years (with BS), 8 years (with MS or MBA) experience in product development experience with a minimum of 3-8 years in medical devices and drug delivery. This experience should ideally span feasibility, design, development, verification and validation
- Experience with delivery system platforms is a plus
- Excellent written and spoken communications skills
- Ability to work with a variety of disciplines and teams in fast-paced environments
- Ability to influence and negotiate internally and externally as a part of global team
- Strong problem-solving and analytical skills
- Working knowledge with medical devices and medical device regulations and standards is preferred
- Travel will be required, as necessary (10%-20%)

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 thisposting 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 long-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

Senior Manager, RDQA

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

The Senior Manager, R&D Device Quality will support the development of medical devices and/or device components of combination products by providing directions on applicable design control, human factors/usability engineering, and risk management processes. This position will engage with all areas involved in the product development process and provide direction and consultation assuring the design control system is effectively established, executed, and maintained. This position will participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, and development of the risk management plans.

**Responsibilities:**

- Provides quality system methodology guidance, support and review for medical device products throughout the design and development and change control processes.
- Actively participates in cross-functional design teams assessing design documentation for quality characteristics, including product requirements, safety risk management, design verification, design validation, manufacturability, serviceability, biocompatibility, sterilization, packaging and reliability.
- Works with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.
- Serves as a technical resource for problem investigations to guide root cause analysis / corrective action development.
- Facilitates and leads design and reliability activities related to Design, Manufacturability, and Reliability (DRM) practices. This includes planning, leading, facilitating, and supporting activities such as robust engineering, reliability predictions, capability analysis, development of CTQ's, VOC, requirements flow down, etc.
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
- Provide quality oversight for clinical batch manufacturing, including equipment qualification, adherence to approved processes, data traceability, and clinical batch release.
- Develop and implement site QA strategies, improve design control and risk management processes, support a consistent and compliant MDCP quality management system, oversee Operations QA activities, and contribute to CAPA investigations and resolution.
- Support regulatory audits and inspections as subject matter expert, while driving quality harmonization, data-informed improvements, and initiatives that enhance process effectiveness and product performance.
- Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals and Medical Devices worldwide.
- Supports changes to quality standards to ensure conformance and continuous improvement.

Qualifications

- 10+ years’ experience working in the Medical Device industry, 2+ years in project management
- Minimum of a BS in Engineering or Scientific discipline; MS preferred
- Strong knowledge of Medical Device development activities
- Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry – Quality Risk Management, 21 CFR 4 Regulation of Combination Products, SOR 98-282 Canadian Medical Device Regulation, ISO 14971 Risk Management Standard, MDD, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices
- Skilled in requirements analysis, including testable and measurable specifications
- Familiar with reliability analysis and test methods and test method validation
- Good verbal (including presentation) and written communication skills, especially technical report writing
- Ability to effectively influence others and work within the Allergan organization as well as partnering with external partners
- Experience interacting with regulatory agencies and notified bodies
- Good knowledge and experience with corrective action and preventive action system, statistical process control, quality risk management, FMEA, DOE and other key tools for managing quality 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 thisposting 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 long-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 anduntil 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>)

Eli Lilly and Company

Reliability Engineering Technician - Lilly Medicine Foundry

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

**Organization and Position Overview**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

As a Reliability Engineering Technician, you will play a critical role in ensuring equipment availability and optimal performance across the site, supporting the delivery of novel medicines for clinical trials. Reporting to the Senior Reliability Manager, you will execute predictive maintenance programs, analyze equipment health data, and drive continuous improvement in maintenance strategies, all in compliance with cGMP and applicable regulatory standards.

**Responsibilities**

In line with the job outlined above, the following are typically the key tasks that would be expected of the role:

- Execute predictive maintenance (PdM) routes, including but not limited to, vibration analysis, ultrasound, thermal imaging, and oil sampling
- Execute precision lubrication activities across manufacturing and utility assets, including lubricant application, re-greasing, and oil top-offs in compliance with OEM specifications and site lubrication standards to extend asset life and reduce unplanned downtime
- Apply precision maintenance techniques, including laser shaft alignment, belt and sheave alignment, torque and tolerance verification in accordance with OEM specifications and site procedures, documenting all findings and completed work in GMARS
- Analyze equipment condition data to identify anomalies, degradation trends, and failure precursors; escalate findings with recommended corrective actions
- Support root cause failure analysis (RCFA) for critical and recurring equipment failures; track corrective actions to closure in GMARS
- Review and optimize preventive maintenance job plans, frequencies, and task content based on performance data and reliability analysis
- Maintain accurate records of all PdM activities, findings, and work orders in GMARS, including asset data, failure codes, and labor hours
- Communicate equipment health status to maintenance, engineering, and operations teams; coordinate reliability-driven work across functions
- Produce clear reports summarizing PdM program performance and overall equipment health
- Provide field troubleshooting support as needed, including outside normal business hours

**Required Qualifications**

- High School Diploma or equivalent and have 2 years experience in the trade or equivalent, or Technical Vocational College associate degree
- Hands‑on experience with condition monitoring technologies (Vibration, thermography and ultrasound)
- Experience with precision maintenance practices
- Working knowledge of rotating equipment, utilities, and manufacturing assets
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) and the ability to learn and navigate site-specific software systems, including CMMS platforms and data analysis tools
- Possess knowledge of CMMS functionalities, workflows, and utilization
- Strong analytical skills with the ability to identify trends and communicate technical findings clearly
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Teamwork and interpersonal skills
- Communication across functional areas
- Computer Skills (Business Applications)
- Level 2 Vibration Analysis
- Level 1 Oil Analysis
- Level 1 Thermography
- Level 1 Ultrasonic
- Familiarized with RCM methodologies and applications
- SMRP Certification (CMRP and/or CMRT)
- Familiarity with mechanical, electrical, and instrumentation systems typical for a chemical manufacturing plant

**Additional Information**

- Role is permanently based at the Lilly Medicine Foundry in Lebanon, Indiana
- Supports a 24/7 operation; flexibility for off-hours support is required
- PPE is required when working in manufacturing areas

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

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

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

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

$33.89 - $49.71

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

\#WeAreLilly

Indiana

Sr. Principal Associate - HSE - Environmental (Water SME)

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

**Job Position Overview**

This role provides strategic and technical water management expertise within Global HSE, supporting global manufacturing, research, and other relevant business operations. The position advances company standards and long-term strategies for wastewater management, water use and recycling, groundwater quality, and drinking water compliance, while translating emerging regulatory and industry developments into practical, risk-based global solutions that support evolving business needs. The role provides senior-level expertise for complex and high-risk water issues, serves as a technical resource on regulatory matters, and contributes to enterprise policy, capital planning, and long-term environmental risk reduction through technical judgment, governance, and cross-functional leadership.

**Responsibilities**

- Define and advance global water management strategies, requirements, and performance standards for manufacturing, research, and other relevant operations through ownership of enterprise technical requirements.
- Assist new sites in obtaining environmental permits and in identifying and implementing operational and engineering controls.
- Establish and evolve global water program data, tools, and metrics — including water use analytics, site self-assessments, and corporate audit findings — to track performance, benchmark progress, and drive sustainable improvement.
- Anticipate, interpret, and influence external water policy, legislation, and regulatory developments, translating them into actionable internal requirements and guidance that advance environmental stewardship and operational flexibility.
- Provide technical support to influence legislation and regulations involving technology-based and water quality-based standards.
- Partner with site and functional HSE teams to strengthen capability, providing the tools, technical guidance, and consultation required to sustain compliance and drive local continuous improvement in water pollution control.
- Provide technical leadership and mentoring to water pollution control professionals across global sites, including leadership of technical forums and communities of practice.
- Represent Lilly, as appropriate, in external industry groups, trade associations, and regulatory forums.
- Coordinate technology initiatives such as best available technique/technology determinations.
- Provide senior-level expertise for complex, high-risk deviation events and permitting oversight upon request.

**Basic Qualifications**

- Bachelor’s degree in Environmental Engineering, Environmental Science, Chemical Engineering, or a related technical discipline
- 10+ years of progressive experience in water pollution control practices, treatment technologies, and regulatory affairs in complex regulated environments.
- Expertise in US Clean Water Act, Safe Drinking Water Act, and Oil Pollution Prevention Act statutes and regulations, EU IPPC licensing, and applicable international requirements.
- Experience in pharmaceutical API manufacturing or another highly regulated industry, including site-based operational experience.
- Expertise in wastewater treatment technologies, water reuse and recycling, and groundwater quality management.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Skills / Preferences**

- Advanced degree (MS or PhD) in engineering, environmental science, or a related technical discipline preferred.
- Strong working knowledge of risk assessment methodologies and their application to environmental decision-making.
- Demonstrated ability to influence senior leaders and cross-functional stakeholders through technical credibility, sound judgment, technical writing, and disciplined project execution.
- Demonstrated ability to translate technical and regulatory complexity into clear recommendations for diverse audiences, including senior leadership, regulatory agencies, and elected officials.
- Experience establishing standards, governance, or enterprise-wide environmental programs in a global, multi-site organization.
- Experience engaging with regulatory agencies, industry associations, and third-party environmental service providers.
- Experience using data, metrics, and digital tools to assess performance, communicate risk, and support environmental decision-making.
- Travel: 10–20% annually; domestic and international travel to manufacturing sites, external conferences, and industry working groups
- Standard business hours with occasional flexibility required to support global time zones.

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

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

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

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

$115,500 - $184,800

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

\#WeAreLilly

Industrial Electrician- Medium Voltage, Instrumentation & Utilites

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

**Organization Overview:**

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

**Position Brand Description:**

The Industrial Electrician has the responsibility of servicing, troubleshooting, and maintaining equipment within the Lilly Technology Center manufacturing site that includes instrumentation, electrical, high purity water, compressed air, steam, chilled water, glycol, city water, and sewers. Responsible for ensuring safe, reliable, and efficient operations across all utility locations, while collaborating with and supporting multiple maintenance crafts to meet operational and maintenance objectives.

**Key Objectives/Deliverables:**

- Perform preventative and corrective maintenance on medium voltage electrical equipment (13.8KV main switch gear, circuit breakers, relays, motor starters, ground fault interrupts).
- Perform preventative maintenance on complex electrical equipment (motor control centers, variable-speed drives, programmable logic controllers, etc.).
- Troubleshoot and diagnose electrical equipment problems and make appropriate repairs to minimize downtime.
- Perform modifications and new installations of electrical equipment (e.g., conduit, conductors, lighting, branch circuits, etc.).
- Diagnose complex electrical problems to effect repairs and restore equipment/systems to operating condition.
- Perform preventative/corrective maintenance and calibration, modifications and new installations on process instrumentation (temperature, pressure, flow, pH, conductivity, TOC, control valves, etc.)
- Demonstrate the ability to read P&ID drawings.
- Consistently comply with safety rules and closely follow approved procedures to ensure cGMP compliance.
- Document all work by following Good Documentation Practices.

**Basic Requirements:**

- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
- Experience maintaining equipment in an industrial utilities environment. Familiarity with any of the following is an advantage: high purity water, compressed air, steam, chilled water, glycol.
- Candidates must hold a valid driver’s license.
- Willingness to respond to call-ins and work scheduled overtime is necessary.
- Ability to lift up to 40 pounds is required.
- Must be able to tolerate exposure to varying temperatures while performing duties outdoors in all weather conditions.
- A minimum of three years of relevant work experience is mandatory.

**Additional Skills/Preferences:**

- Associate's degree, Technical Certificate in an electrical discipline, or equivalent industrial electrical experience; military electrical training accepted. Experience with medium-voltage electrical systems (4.16kV preferred).
- Experience performing and troubleshooting electrical maintenance equipment in a manufacturing, industrial, or production environment.
- Ability to read, interpret, and work from electrical schematics, prints, and technical documentation.
- Knowledge of safe maintenance practices, work procedures, and documentation requirements.
- Proficiency using CMMS software (e.g., Maximo) for work order management and maintenance tracking. Microsoft Applications Knowledge (Word, Excel, Outlook, PowerPoint).
- Strong communication skills and ability to work effectively in a team environment.
- Experience collaborating with multiple skilled trades and supporting cross-functional maintenance activities.

**Education Requirements:**

- High school diploma or equivalent

**Additional Information:**

- This position is scheduled for 8 hours per day, Monday through Friday.
- Temporary shift changes may occur.
- Hazardous operations within Utilities include exposure to acid, steam, caustic substances, high pressure, and high temperatures.
- Personal protective equipment is required at all times.
- Work involves awkward positions, cramped quarters, ladders, and scaffolding.
- Employment requires working during summer and year-end company breaks.

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

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

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

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

$21.27 - $41.25

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

\#WeAreLilly

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

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

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

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

$21.27 - $41.25

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

\#WeAreLilly

Syner-G BioPharma Group

Regional Director, Southeast

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

We are seeking a dynamic and motivated Regional Director of Technical Operations, Southeast to lead our operations and growth strategy in the Raleigh-Durham area, with accountability for performance and client satisfaction across a diverse portfolio of technical projects. This role is responsible for developing and executing the regional account strategy, building and leading teams, and fostering a culture of delivery excellence.

**WORK LOCATION**:

Travel to client sites may be required based on project demands and client expectations.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented or changed as necessary.)

*Account Management and Delivery:*

- Leads a high-performing engineering organization responsible for the successful operational delivery of projects across the regional portfolio of client projects.

- Acts as a true partner in meeting the needs of clients’ business. Must listen, be passionate about exploring opportunities, and solve client problems proactively on an ongoing basis.

- With partners in Commercial, develop and executes the regional account strategy, including proactive client retention and expansion as well as identifying and supporting development of new business.

- Engages in active participation in the RTP life sciences community with an established network of professional relationships. Drives visibility through industry events, social media, and other marketing initiatives and engagement opportunities.

*Business Acumen and Collaboration:*

- Builds productive relationships with Commercial, Marketing, and other functions (HR, Finance, Talent Acquisition) to support delivery of services to the customer and minimize risk to the business.

- Partners with other service delivery groups to identify and pursue cross-sell opportunities outside of Technical Operations.

- Develops annual operating budgets and periodic forecasts, manages regional P&L to meet regional and company goals.

*Leadership:*

- Builds, develops, and mentors a high-performing engineering organization focused on technical competence and proactive service to the client.

- Works to elevate the way our teams think and operate, creating a culture that results in an engaged workforce.

- Creates an environment of inclusion and recognition that emphasizes development and reinforces the commitment to our people as our most important asset.

**QUALIFICATIONS AND REQUIREMENTS:**

*Education*:

- Bachelor’s degree in Engineering, Operations, or related field or equivalent experience with strong business and financial aptitude; MBA desirable

*Experience*:

- 10-15 years of overall life sciences industry experience.

- 5-10 of experience in project delivery, engineering operations or technical program management.

- 5 or more years of leadership in GMP manufacturing facility design, construction, startup, engineering, and/or operations.

- Demonstrated business development success, with the ability to sell services and expand client relationships in a competitive environment.

- Strong experience in one or more of the following areas: Capital Projects, Facilities Engineering, Process, Automation, CQV, and/or Project Management.

- Ability to build, develop, and motivate high-performing teams to support and deliver multiple projects under demanding timelines.

- Proven track record of project delivery for laboratory and/or manufacturing facilities and operations in regulated industries such as biotech, pharmaceuticals, or advanced therapeutics.

- Exceptional customer relationships and client management skills.

- Excellent communication, leadership, and organizational skills.

*Preferred Qualifications:*

- Prior experience working as a consultant or managing a portfolio of client projects.

**ESSENTIAL FUNCTIONS**:

*Physical Demands:*

The physical demands described here are representative of the requirements 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.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment:*

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

North Carolina

Sr. Principal - Industrial Hygienist

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

*Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.*

**Main Purpose and Objectives of Position:**

The Industrial Hygienist is part of the Lilly Richmond Active Pharmaceutical Ingredient (API) Manufacturing Health, Safety, and Environmental (HSE) team and provides technical expertise and support in the development, implementation, and maintenance of HSE industrial hygiene (IH) programs and other HSE programs, as needed. This position will serve as the primary IH contact for a variety of areas (e.g., such as monoclonal antibodies and antibody drug conjugates manufacturing, laboratories, utilities, warehouse, etc.).

In the project delivery and startup phases, the industrial hygienist role will be fluid and dynamic as we endeavor to support project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows through startup to full scale GMP manufacturing.

Post start-up, this role will continue to be the subject matter expert and daily support for IH programs and other assigned HSE programs (as needed) within their assigned work areas.

**Key Responsibilities for this role include:**

- Participate in project design meetings, support risk assessment and industrial hygiene/exposure control decisions.
- Responsible for developing and implementing industrial hygiene written programs and applicable trainings.
- Develop and support the industrial hygiene implementation strategy working directly with the areas for implementation, troubleshooting, and auditing compliance.
- Participate in the development of the HSE operational readiness plan for the Lilly Richmond API facility as a collaborative, inclusive, and energetic member of the HSE team.
- Be a technical resource for assigned programs (e.g., hazard communication, exposure assessment, biological safety, personal protective equipment, etc.).
- Conduct workplace assessments to identify chemical, physical, and biological hazards, and develop IH prioritized monitoring plans (e.g. chemical, noise monitoring, ergonomics, and other assessments). Conduct the analysis of exposure assessment results and prepare reports on findings.
- Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, assure safety and compliance of new systems, and assist in setting requirements to assure safe and compliant startup.
- Be a resource to the operational areas in helping them understand the regulatory requirements of their areas and programs; work with them in implementing solutions that comply with these regulations and programs.
- Complete internal HSE audits/assessments, lead/support incident investigations, assist with trending HSE data and metrics compilation, and support the development of long-term plans to drive program improvements.

**Requirements:**

- Bachelor’s degree in Industrial Hygiene or related field
- 3+ years of Industrial Hygiene experience within cGMP manufacturing (pharmaceutical or chemical manufacturing preferred)
- Experience in GMP Manufacturing environment and potent compounds.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

**Additional Preferences:**

- Experience in antibody drug conjugate manufacturing (drug substance and drug product).
- Demonstrated skills in technical expertise and self-motivation.
- Attention to detail and ability to be flexible depending on operational needs.
- Effective communication skills (oral, written, presentation, and negotiation) appropriate for all levels in the organization and a willingness to share information.
- A self-motivated, action-oriented, high-energy team player with demonstrated ability to work effectively in a highly collaborative organizational culture.
- Practices and earns trust and mutual respect.
- High degree of business and personal ethics and integrity.
- Analysis/problem assessment skills, communication (oral and written) skills, information monitoring skills, quality orientation, and teamwork/interpersonal skills.

**Other information:**

- Tasks will require entering manufacturing and laboratory areas, which require wearing appropriate PPE.
- Must carry a cell phone as position will support 24/7 manufacturing operations.
- Onsite position

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

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

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

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

$65,250 - $169,400

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

\#WeAreLilly

Virginia

Sr. Principal Associate – Environmental

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

Lilly is currently constructing an advanced manufacturing facility for the production of API bioconjugates and monoclonal antibodies (mAb), including new modalities, in Goochland County, Virginia (Richmond, VA). This facility is intended to provide capacity for current and future products. This is a unique opportunity to be part of the leadership/startup team for a greenfield manufacturing site, and the successful candidate will help build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.

**Position Overview**

The Sr. Principal Associate – Environmental is part of the Lilly Richmond Health, Safety, and Environmental (HSE) team and serves as the site's recognized technical authority for environmental compliance, setting direction for the development, implementation, and maintenance of environmental programs and leading site permitting efforts.

In the project delivery and startup phase of the project, the HSE roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows to full-scale GMP manufacturing through startup.

Post start-up, this role will continue to serve as the senior subject matter expert accountable for assigned environmental programs and provide independent compliance oversight of operations for pharmaceutical API/mAb manufacturing units.

**Key Responsibilities**

- Own, develop, and lead implementation of the environmental operational readiness plan for the Lilly Richmond facility as a collaborative, inclusive, and energetic member of the HSE team. Examples of site environmental programs that this role may support include the Title V air program, wastewater, refrigerants, non-hazardous and hazardous waste (RCRA), SPCC, and DOT/hazardous materials, among others.
- Partner with the project team as the accountable environmental stakeholder, shaping and endorsing environmental-related design decisions, construction, and startup plans while ensuring decisions meet project deliverables and compliance requirements, leveraging existing Lilly knowledge and incorporating external experiences and learning.
- Develop and roll out environmental programs, procedures, tools, and overall management systems, including training, coaching, and onboarding of new staff to build technical capability and a strong HSE culture at the site.
- Lead the partnership with Operations, Maintenance, and Engineering functions to govern change, assure safety and compliance of new systems, and set the requirements to assure a safe and compliant startup.
- Ensure applicable internal and external regulatory reporting is coordinated and completed on time, including incorporating second-person verification, as needed.
- Serve as the recognized expert for the operational areas, enabling them to understand and apply the regulatory requirements of their areas and programs; work with them to implement solutions that comply with these regulations and programs. Facilitate the implementation of programs and permits.
- Monitor and interpret emerging regulations and Lilly Global HSE standards, assess site impact, and drive implementation plans in advance of effective dates.
- Lead internal HSE assessments and support incident investigations, including root cause analysis, and set the multi-year improvement plan for assigned environmental programs.

**Basic Requirements**

- Bachelor's degree in environmental engineering, chemical engineering, chemistry, or a related field of study
- Minimum 5 years of experience in chemical manufacturing or a GMP-regulated environment
- Experience applying environmental regulations and developing environmental programs
- Experience interfacing with HSE-related regulatory agencies
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

**Additional Skills/Preferences**

- Experience in the pharmaceutical industry
- Excellent organization and time management skills, as well as strong analytical skills and a systematic and structured way of working
- Strong collaboration and communication skills
- Demonstrated ability to lead and influence cross-functional and technical teams without direct authority

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

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

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

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

$65,250 - $169,400

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

\#WeAreLilly

Sr. Principal Engineer- Utilities

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

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

The Utilities Engineer is responsible for establishing and maintaining reliable operation and qualified state of clean utility systems and supporting grey systems that support Biotech manufacturing. The Utilities Engineer will ensure that processes are in-control, compliant, and capable of meeting manufacturing needs, while also driving continuous improvement.

**Key Responsibilities:**

- Ensure a safe working environment by following safety rules and helping improve the safety culture.
- Provide clean system engineering expertise as an active member of area team.
- Clean system unit operations and equipment are maintained and are in a qualified and reliable state.
- Establish and/or monitor the critical parameters for all clean systems to ensure that these are in control.
- Lead Troubleshooting efforts to resolve difficult unit operations, equipment and operational issues.
- Evaluate all activities for impact on qualified state of equipment and utilize appropriate tools as necessary.
- Supporting the grey utility

**Facility Start-Up:**

- Provide engineering support to the Global Facility Delivery Team (Lilly’s global large scale capital delivery team) with a strong focus on right first time and on-schedule facility start-up. This includes design reviews, process safety assessments, user requirements, C&Q support, unit operation shakedown and start-up, facility operational readiness.
- Define and own relevant aspects of the overall integrated operational readiness plan (e.g. SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, performance qualification requirements/protocol development, etc.)
- Own the qualified state of equipment for respective area of responsibility
- Develop and implement unit operation and equipment control strategy to sustain and optimize utilities systems in support of manufacturing operations
- Support initial operations training requirements as the equipment and area SME

**Safety:**

- Take responsibility for the safe design and safe operation of the equipment within the area.
- Actively participate in safety-related activities (audits, hazard reviews, pre-start up safety reviews) to drive ongoing safety improvement.

**Bio-process Technical Support:**

- Be the point of contact and be the technical expert for equipment and processes in area of responsibility. This includes clear understanding of unit operations and associated equipment operations.
- Monitor the utility systems and optimize the unit operations and equipment performance.
- Lead troubleshooting efforts relating to unit operations, equipment and operational issues.
- Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve unit operations and equipment issues.
- Respond to unit operations issues and equipment failures, document appropriately and ensure resolution of events through appropriate actions.
- Communicate effectively with others, especially team members, operations and crafts personnel.

**Maintain Qualified and Reliable State:**

- Evaluate all activities for impact on qualified state of unit operations/equipment and utilize appropriate business processes as necessary (change control etc).
- Responsible for system/component classification and maintenance strategy for equipment.
- Implement corrections, corrective actions, and countermeasures arising from investigations.
- Participate in Periodic Reviews for systems and equipment.
- Lead IQ/OQ/PQ activities (including commissioning activities of new unit operations/equipment)

**Asset Management:**

- Develop scope for capital projects targeted at both short- and longer-term needs. Act as user representative for local projects.
- Understand equipment reliability issues with the objective of improvement.
- Aid the coaching of operators and maintenance technicians in the effective use of equipment

**Improve Business:**

- Identify and drive improvement opportunities (procedural changes, upgrades, projects etc) associated with unit operations/equipment within the area.

**Basic Minimum Qualifications:**

- Bachelor’s Degree required. Degree in Engineering or related technical field preferred.
- Minimum of 5 years’ experience in Utility Engineering Teams, preferably in a manufacturing GMP environment.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Skills/Preferences:**

- Ability to build and maintain strong relationships with site stakeholders including site lead team, production, quality, safety and global engineering groups.
- Travel up to 10%. At times will travel offsite to other Lilly locations, other companies, conferences, off-site training or to support capital projects.
- Knowledge of one or more of the following areas; Clean Utilities, Black Utilities, HVAC, Electrical.
- Excellent communication skills

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

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

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

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

$66,000 - $171,600

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

\#WeAreLilly

Principal Associate - HSE

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

*Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.*

**Position Overview:**

An exciting opportunity has arisen for an experienced HSE professional to join the Richmond Health, Safety, and Environmental (HSE) team and take a leading role in developing, maintaining, and continually improving the HSE Management System/Program at our new manufacturing site.

In the project delivery and startup phase of the project, the HSE roles will be fluid and dynamic as we endeavor to support project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows to full scale GMP manufacturing through startup.

**Responsibilities**:

- Own the development, implementation, and ongoing improvement of the Site HSE Management System, including setting its scope, priorities, and standards.
- Develop, integrate, and continuously improve the site Safety/Health program, serving as site program owner for multiple program elements and making independent technical decisions within those areas.
- Serve as the site's recognized technical expert on Safety/Health, interpreting legislation, corporate standards, policies, and industry guidance and advising site leadership on compliance decisions.
- Lead the development of a safety culture with integrated safety practices and open safety conversations.
- Develop and deliver high quality Safety/Health training and communications.
- Drive implementation of site Safety/Health initiatives.
- Understand and implement Safety/Health requirements in a project environment through knowledge of applicable legislation and industry practices.
- Own site Safety/Health performance metrics, analyzing trends and translating findings into corrective and preventive actions.
- Lead site audits and self-assessments, and represent the site in management reviews, corporate audits, and external regulatory audits.
- Collaborate with site manufacturing and technical support personnel to manage Safety/Health aspects of new / established processes.
- Interact with external (e.g., service providers, vendors, consortiums, academia) and internal partners (e.g., Global HSE, other sites in the network, etc) as required.
- Mentor and build the technical capability of HSE colleagues and site personnel, sharing expertise across the network.
- Represent HSE in required Site team and HSE Team meetings, providing input on site decisions.

**Basic Requirements:**

- Bachelor's degree required in occupational health, safety, engineering, chemistry, biology, environmental health, or a related scientific or technical discipline.
- Minimum of 5+ years of experience within highly regulated GMP manufacturing environments.
- Demonstrated experience independently interpreting and applying Health and Safety regulations and developing Health and Safety programs.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Skills/Preferences:**

- Previous experience supporting greenfield, startup, or major capital project environments in pharmaceutical, or other regulated manufacturing settings.
- Excellent organization and time management skills, as well as strong analytical skills and systematic and structured way of working
- Strong collaboration and communication skills
- Demonstrated ability to lead cross-functional and technical teams and to influence and align stakeholders without direct authority

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

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

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

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

$65,250 - $169,400

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

\#WeAreLilly

Engineering Technician - Night shift

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

**Engineering Technician – Night Shift**

**At Lilly**, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global leader in healthcare, committed to discovering life-changing medicines, advancing disease management, and supporting our communities through philanthropy and volunteerism. We put people first and strive to make a meaningful impact every day.

**Position Summary:**

The Engineering Technician at our Concord, NC facility plays a key role in supporting Parenteral Operations, our customer, by ensuring the efficient setup and operation of Pre-Filled Syringe and Isolator Equipment. This position requires hands-on engineering maintenance expertise to assist with equipment setup, operational support, troubleshooting, repairs, and ongoing maintenance.

The ideal candidate will demonstrate a strong understanding of customer needs, collaborate effectively with internal teams, and provide responsive, courteous support. Success in this role requires technical proficiency, problem-solving skills, and a commitment to delivering excellent customer service in a dynamic manufacturing environment.

**Key Responsibilities:**

- Promote a safety-first, quality-always culture in all tasks and interactions
- Improve equipment uptime, line efficiency, and overall equipment effectiveness (OEE)
- Perform condition monitoring, troubleshooting, and provide operational support
- Diagnose and repair precision filling equipment with strong mechanical aptitude
- Collaborate with engineering and production teams to resolve equipment issues promptly
- Assist with equipment setup and changeovers to support production needs
- Adhere to all GMP and quality standards
- Must have the ability to quickly and accurately diagnose the root cause of a problem and properly implement corrective actions to minimize downtime
- Accurately document maintenance activities and corrective actions
- Support cross-functional tasks and assist outside primary responsibilities as needed
- Work independently and manage priorities under pressure

**Minimum Requirements:**

- High School / GED minimum
- Visa Sponsorship: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Basic Qualifications:**

- High school diploma or GED
- Minimum of 5 years’ experience in production maintenance
- Strong mechanical aptitude and hands-on technical skills
- Proficient with basic hand tools
- Detail-oriented with a commitment to quality and precision
- Familiarity with safety protocols and proper PPE usage
- Physically able to stand for extended periods
- Effective team player with strong interpersonal skills
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Preferred Qualifications:**

- Associate’s degree or technical certification in a related field is a plus
- Knowledge of FDA and GMP regulations
- Experience operating high-speed, automated production equipment, preferably Syringe/Vial Filling systems utilizing Isolator technology
- Ability to quickly learn and apply new procedures
- Experience working in a classified manufacturing environment
- Familiarity with Computerized Maintenance Management Systems (CMMS) platforms
- Strong verbal and written communication skills
- Customer-oriented mindset with a proactive approach
- Analytical thinker with strong problem-solving abilities

**Additional Information:**

- Flexibility to work overtime or adjust schedule based on production demands
- Following a Monday–Friday, 8-hour training period, the role transitions to a 12-hour 2-2-3-**night shift** schedule
- Willing and able to respond to off-hour emergencies as needed
- Open to travel for training and professional development opportunities

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

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

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

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

$21.27 - $41.25

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

\#WeAreLilly

Tris Pharma

Packaging Mechanic

**Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company** with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

**Our science and technology make us unique, but our team members set us apart**; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

Our Packaging Department is growing, and we have openings for Mechanics at various levels requiring various levels of experience. Title and salary commensurate with experience. **The Packaging Department works 10-hour days, Monday-Thursday, in our Monmouth Junction, NJ** **facility. Current open positions are for 1st & 2nd shifts.**

**Hours are (1st shift) 5:00 AM - 3:00 PM & (2nd shift) 3:00 PM – 1:00 AM**

The Packaging Mechanic is responsible for supporting and assisting the Packaging Department in ensuring efficient packaging of goods by performing packaging equipment maintenance including, but not limited to: troubleshooting, repair, upgrade, preventive maintenance (PM), etc. on various types of packaging equipment including, but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) requirements.

**Essential Functions & Responsibilities:**

- Responsible for all aspects of Packaging equipment maintenance in accordance with company policies, SOPs, cGMPs and FDA requirements
- Performs packaging line change overs and startups
- Assists Packaging Operations/Quality Assurance (QA) activity during the running of packaging lines
- Performs routine and complex work related to the troubleshooting, repair, and upgrade of all packaging equipment including but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc.
- Responsible for performing PM, repair and continuous improvement of packaging equipment
- Assists in performing root cause analysis on equipment failures to support investigations
- Ensures packaging equipment is operating safely at all times

Requirements

**REQUIREMENTS:**

**Minimum education and years of relevant work experience required:**

**Mechanic I:**  High School diploma or equivalent and minimum **3 years** packaging mechanic experience in the pharmaceutical or biotechnology industry.

**Mechanic II:**  High School diploma or equivalent and minimum **5 years** packaging mechanic experience in the pharmaceutical or biotechnology industry.

**Special knowledge or skills needed and/or licenses or certificates required:**

- Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes
- Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
- Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
- Hands on experience with repair, maintenance and troubleshooting of pharmaceutical packaging equipment (i.e., fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc.)
- Basic PC skills
- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
- Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
- Planning, organization and time management skills including the ability to support and prioritize multiple projects
- Fluent in English (verbal and written)
- Ability and willingness to work additional hours as required by business needs

**Special knowledge or skills needed and/or licenses or certificates preferred:**

Trade school or certification

**Physical requirements:**

Manufacturing based position

Ability to lift up to 50 lbs

Ability to use Personal Protective Equipment (PPE)

Ability to stand for extended periods

Anticipated salary range: $73,000 – 85,000. Base salary to be offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

HPC Systems Administrator

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

**_Where AI Meets Medicine: Build the Future of Drug Discovery in the Heart of Silicon Valley!_**

Making medicine that’s never been made means doing what’s never been done. If you’re an engineer, scientist, or builder who thrives on problems no one has solved before, this is your invitation; we want you on the team. We are ready to challenge the status quo and push medicine forward, all in the name of health. Are you up for the challenge? If so, join us!

**About the Lilly and NVIDIA Partnership**

Lilly and NVIDIA are launching a new AI co-innovation lab in the heart of Silicon Valley — an up-to-$1 billion, multi-year commitment to solve drug discovery’s toughest challenges. The lab brings Lilly scientists, technologists, chemists and biologists together with NVIDIA engineers under one roof. Together, we are building purpose-built foundation and frontier AI models trained on Lilly data at scale, tightening the feedback loop between automated wet labs and computational dry labs, designing the next generation of medicines for millions of patients across the globe.

**What You’ll Be Doing**

The HPC Systems Administrator will build and operate scalable AI and high-performance computing platforms that power advanced machine learning and scientific workloads. You will partner with AI scientists, engineers, and domain experts to enable efficient model training, inference, and experimentation across GPU, cloud, and on-premises environments. Through platform engineering and automation, you will improve productivity, performance, and access to advanced computing resources while ensuring the reliability, availability, and efficiency of Lilly's AI and HPC infrastructure.

**How You’ll Succeed**

- Deliver highly available, secure, and performant AI and HPC platforms that meet the needs of research and engineering teams.
- Drive operational excellence through automation, standardization, monitoring, and continuous improvement.
- Balance infrastructure reliability, scalability, and cost efficiency across environments.
- Enable efficient ML workflows through automation for orchestration, resource scheduling, data access, and reproducibility
- Collaborate effectively across scientific, engineering, and infrastructure teams to solve complex technical challenges.
- Adapt quickly to evolving AI, GPU, and HPC technologies and translate new capabilities into business value.

**What You Should Bring**

- Deep expertise in Linux systems administration, automation, and infrastructure management, with strong scripting skills in Python, Bash, and/or Ansible.
- Experience building, administering, and optimizing large-scale HPC, GPU, or AI/ML computing environments, including job scheduling and resource management platforms such as Slurm or Grid Engine.
- Proficiency with automation, configuration management, and container technologies, including Ansible, Kubernetes, Docker, and related tooling.
- Solid understanding of distributed computing, high-performance networking, storage architectures, and cluster infrastructure.
- Experience supporting large-scale distributed training and inference workloads across multi-GPU and multi-node environments.
- Knowledge of GPU infrastructure, hardware lifecycle management, monitoring, and observability practices.
- Demonstrated ability to solve complex infrastructure challenges, identify root causes, and implement scalable automated solutions.
- Good communication and collaboration skills, with the ability to work effectively across researchers, engineers, and infrastructure teams.
- Experience running NVIDIA GPU infrastructure and hardware lifecycle operations, including GPU monitoring, partitioning, diagnostics, and out-of-band server management using industry-standard tools and protocols.
- Experience supporting regulated or critical environments is a plus.
- Experience operating AI/HPC infrastructure in cloud environments such as AWS, Azure, or GCP.

**Your Basic Qualifications**

- Bachelor’s Computer Science, Electrical/Computer Engineering, Systems Engineering, or a related technical field.
- 5 years’ experience deploying, administering, or supporting large-scale HPC, GPU, or distributed computing environments in an enterprise or research setting.

**Location & Work Flexibility**

This role is based at our Silicon Valley Hub. We offer a flexible hybrid work model, with **three days onsite and two days working remotely each week**, supporting both collaboration and work‑life balance.

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

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

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

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

$141,000 - $231,000

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

\#WeAreLilly

Director-Engineering Design Lead

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

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through partnerships with design, construction and qualification contractors.

Many of the assets delivered focus on manufacturing of medical innovations and delivering innovative solutions to patients and support an expansion in supply of existing medicines.

Responsibilities for a Director-level DL (Design Lead) include:

- Overall design delivery for capital project(s) for a multi-node program or network, and manage a team of DLs on node-level design (manufacturing buildings, utilities, or support systems).
- DL teams will be a mixture of Lilly team members and external partners fully accountable in the project location for project technical success.
- Directly influences Sr. Management on asset design and/or delivery approaches.
- Lead the identification of the applicable Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements and guidance (both internal and external).
- Actively leads delivery team to expand on their knowledge of design processes based on a history of project delivery.
- Coordinate all design for the Project Manager during all design phases of the project and be responsible in delivering the conceptual design review and basic design review.
- Direct the development of the design requirements.
- Command of the design schedule to meet the project needs.
- Often participate in the selection of the A/E firms.
- Coordinate with A/E firms to develop earned value progress systems to measure progress by discipline (monitor work versus invoice amounts).
- Own design decisions and coordinate information flow between the design team and system owners.
- Responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer. Clear articulation of want vs need for asset and facility requirements.
- Responsible for design activities and governance, resolving design-related problems.
- Examine areas of inefficiency and develop strategies for improvement to direct the design team to meet or improve on the design hours plan.
- Instruct the development of standard operating procedures, project delivery work instructions, and/or best practices related to design/verification and ensure they remain current with industry best practices. Influences the network in the adoption of those industry best practices.
- Review and approve along with the respective Project Manager the key design project personnel (both internal and external resources).
- Work with Engineering Tech Center resources and other key project team technical/constructability resources to address and resolve design issues, and issue formal reports accordingly. Influences key technical decision makers on issues of corporate significance.
- Ensures replication is achieved during design when applicable, even in new situations.
- Support the Project Manager for value engineering exercises efforts to maximize project opportunities and deliver significant site impact and directly contribute meaningful ways to reduce cost through design.
- Participate in KPI reviews/assessments.
- Participate in the selection of the verification professional services.
- Accountable for the development of the Project Verification Plan, Traceability Matrix, and risk assessments (not necessarily lead the execution).
- Coordinate verification for the Project Manager during the verification phase of the project.
- Accountable for the discrepancy tracking and management in the Verification phase and uses root cause investigation techniques to resolve problems.

Basic Qualifications:

- BS in Engineering (Chemical or Mechanical strongly preferred)
- Minimum of 20 years manufacturing and/or engineering in support of pharmaceutical or API networks
- Ability to work at the site of the project on a weekly basis. This position reports through Indianapolis but is located at site of the supported project.

Additional Preferences:

- Strong manufacturing and engineering background.

Additional Information:

- Travel is required for this role (20%, 1-2 weeks/month until relocation to project site)

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

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

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

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

$151,500 - $264,000

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

\#WeAreLilly

Alabama

Insmed Incorporated

Manager, Upstream Pilot Plant

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Manager, Upstream Pilot Plant on the Manufacturing team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Manufacturing, you’ll play an essential role in the successful production of high-quality Gene Therapy products. Your responsibilities will span a variety of activities, including upstream process execution (cell culture and bioreactor operations), maintaining GLP-compliant documentation, operating and maintaining cell culture equipment, authoring records and procedures, and contributing to continuous improvement initiatives within viral vector manufacturing.

**What You'll Do:**

In this role, you’ll have the opportunity to execute upstream processes, including cell culture expansion, bioreactor operations (bench, pilot, and production scales), and media/buffer preparation. You’ll also:

- Operate and maintain upstream bioprocessing equipment such as wave/rocking platforms, stirred-tank bioreactors, incubators, and automated control systems.
- Prepare, sterilize, and manage cell culture consumables while ensuring aseptic technique in all operations.
- Maintain strict adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, technology transfer documents, and campaign summary reports.
- Ensure compliance with company SOPs, training requirements, and best practices for scale-up and technology transfer.
- Maintain facility readiness and support inspections through vigilant oversight of upstream operations.
- Utilize Quality Systems and Enterprise Resource Planning (ERP) tools to record and track production activities.
- Provide upstream process subject matter expertise and take ownership of assigned deliverables.
- Demonstrate strong technical writing and communication skills.
- Always maintain a safe working environment and remain current with assigned training.

**Who You Are:**

You have a bachelor’s degree in Biology, Chemical Engineering or Biochemistry along with 5 years of experience in in upstream process development or manufacturing support in bioprocessing.

You are or you also have:

- Hands-on experience with mammalian or microbial cell culture, seed train expansion, bioreactor operations (bench, pilot, or production scale), and media/buffer preparation.
- Knowledge and application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Proven ability to collaborate effectively within cross-functional teams in a manufacturing or development environment.
- Experience supporting manufacturing investigations, root cause analysis, and deviation resolution in biologics production.
- Familiarity with Quality Systems, Enterprise Resource Planning (ERP) platforms, and electronic documentation systems.

**Nice to have (but not required):**

- Preferred: Experience conducting manufacturing investigations in biologics or cell culture based production.

**Where You’ll Work**

This role is based out of our San Diego, CA office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

**Travel Requirements**

Minimal travel expected

\#LI-BA

\#LI-ONSITE

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Senior Director, Engineering - Advanced Therapies

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

**Overview:**

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

The Senior Director of Engineering is directly responsible for managing the site engineering function and ensuring it has the necessary capacity, capability and leadership structures in place to deliver the site engineering deliverables in support of the manufacturing plan. They provide administrative and technical leadership for the site engineering function including process engineering, process automation, maintenance, utilities, plant and project engineering, and engineering competencies.

They are a member of the Lilly Lebanon Advanced Therapies Site Lead Team and report directly to the Site Head. The Lead Team has collective responsibility to develop and implement the strategic direction, organizational capability and management of the site. Primarily, the members of the team drive the site toward achieving long term business objectives; they continuously develop the business and the organization for the future bearing in mind corporate objectives and the continuously changing external environment; and they manage issues that span multiple teams in the organization and extend into the broader corporate/external context.

In the project delivery phase and startup phase of the project, the Site Lead Team roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

**Startup Phase:**

- Be a collaborative, inclusive, energetic leader and support the broader lead team to:
- Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
- Defines the site engineering priorities & roadmap in order to develop and implement the systems and processes needed to run the site. This includes leveraging existing Lilly knowledge where necessary, but also incorporating external experiences and learning.
- Serve as a key member of the site HSE Lead Team, ensuring safety focus throughout project delivery and startup.
- Support the project team to deliver the facility as the end user. Providing feedback and support on design decisions, commissioning strategies, startup plan, etc. Collaborate to ensure the right decisions are made to meet project deliverables and longer term strategic goals for the site.
- Develop and adapt organizational structure to provide correct and capable resources and management to deliver the site to a full scale GMP manufacturing scale.
- Ensure the systems are in place and executed to establish the initial qualified and safe state for equipment, processes, utilities and facilities
- Build technical relationships with the relevant corporate departments and sponsors strategic corporate initiatives at a site level.

**Post Startup:**

- Continue to define and support the site engineering priorities & roadmap; integrate the functional agenda with site priorities.
- Ensure the site is in compliance with corporate standards and policies for the engineering function, including applicable environmental, safety, and quality requirements.
- Have external focus, benchmark best practices across network and externally
- Ensure equipment, processes, utilities and facilities remain and operate in a qualified and safe state; Ensure that equipment maintenance and utilities operation are performed and documented to the highest standards of safety and quality.
- Manage the site investment processes for assets (planning, prioritization, resourcing, project management, capital accounting and reporting). Own the development and delivery of the capital investment plan in accordance with the site objectives for new products, recapitalization of assets, and facility modernization.
- Ensure that a robust control system exists to manage the business, identify compliance issues and escalate issues appropriately is established and maintained.
- Develop the future management and technical leadership for the site and for potential global assignments.

**Minimum Requirements:**

- Minimum of a Bachelor's degree (or equivalent) in a relevant Engineering discipline
- 10+ years of experience in a leadership role managing operations within the pharmaceutical industry, with specific knowledge and understanding of cGMPs and how they apply to manufacturing operations.
- Direct experience in Drug Substance or Drug Product manufacturing.

**Preferences:**

- Must have a strong ability to form effective relationships at all levels. This candidate must be able to work closely with the Site Leadership team to ensure alignment with corporate objectives and internal decision making processes, and be able to connect and communicate effectively with all levels of the organization on site.
- Should have a demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.
- Should have experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe and successful work environment.
- Experience with manufacturing of advanced therapies (Biotech, Cell and/or Gene Therapy) is preferred.

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

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

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

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

$168,000 - $246,400

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

\#WeAreLilly