Senior/Sr. Principal Engineer, Quality Assurance

436 Eli Lilly Nederland B.V.; Katwijk; On-site; EUR 60,000 - 99,000; Full time

Job summary

Eli Lilly Nederland B.V. in Katwijk, Netherlands, seeks a senior quality/engineering professional to lead site facility, utility, and equipment qualification activities on a 12‑month contract with potential for permanence.

You will ensure cGMP compliance across design, verification, commissioning and lifecycle management, act as site SME for FUME Quality Systems, and partner with Global Facility Delivery, QA and engineering teams to deliver compliant, high‑quality manufacturing assets.

Qualifications

• BS in Engineering or a science-related field; 8+ years pharma quality/engineering with FUME quality systems experience.
• Experience with API/drug product manufacturing, OSDS, QA or Engineering.
• Hands-on experience with quality engineering documentation review/approval.
• Experience with capital project delivery.
• Excellent cross-functional and written/spoken communication skills.

Responsibilities

• Provide cGMP and Lilly Global Quality Standard expertise with Global Facility Delivery team, site engineering, staff, and selected firms to support verification/qualification of site facilities, utilities and equipment.
• Serve as site SME for Facility, Utility, Maintenance and Equipment (FUME) Quality Systems and asset lifecycle compliance.
• Provide strategic technical leadership for qualification, verification and maintenance of GMP assets.
• Provide technical and quality review/approval of project documents to ensure compliance with Global Quality Standards.
• Provide quality oversight for verification/qualification of manufacturing facilities, utilities, equipment and supporting systems.
• Mentor engineering and QA teams on quality systems execution.
• Maintain and improve FUME quality systems.
• Contribute to APRs, QPPA, asset qualification maintenance strategies and PC systems reviews.
• Conduct gap assessments of global requirements and ensure governing standards are implemented.

Skills

C&Q / CSV oversight

API/OSD QA

Documentation review/approval

Capital project delivery

Cross-functional communication

Attention to detail

Computer systems validation

GMP knowledge

Statistical tools

Interpersonal skills

Task prioritization

QA/QC/Manufacturing/Engineering/Reg.

Instrument Qualification activities

Education

BS in Engineering or science-related field

Tools

Automation validation tools

Job description

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.

About the Katwijk Site

This position starts with a 12-month contract, with the intention of offering a permanent contract based on mutual fit. (Dienstverband: tijdelijk met uitzicht op vast) Eli Lilly is investing €2.6 billion in a new state-of-the-art manufacturing facility in Katwijk, Netherlands. This facility will produce oral medicines for cardiometabolic health, neuroscience, oncology, and immunology, incorporating next-generation manufacturing technologies including dock-to-dock automation, paperless manufacturing, and process analytical technology while achieving carbon neutrality and zero waste to landfills.

Responsibilities

The role provides guidance, consultation, and oversight across the design, verification, startup, and ongoing life cycle management of site facilities, utilities, and equipment. It is essential to ensuring cGMP compliance throughout the design, delivery, verification, qualification, commissioning, startup, and life cycle maintenance of site assets, utilities, and processes. The role also maintains external linkages and supports preparation for pre-approval and general inspections by regulatory agencies.

• Provide cGMP and Lilly Global Quality Standard expertise working with Global Facility Delivery team, site engineering team, Lilly site staff, and selected firm to support the verification and qualification of site facilities, utilities, and equipment, employing Quality by Design (QBD) and Quality Risk Management principals and ensuring the integration of Global Quality System requirements into the design.
• Serve as the site subject matter expert for Facility, Utility, Maintenance, and Equipment (FUME) Quality Systems and asset lifecycle compliance.
• Provide strategic technical leadership for qualification, verification and maintenance of GMP assets.
• Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
• Provide quality oversight for the verification and qualification of manufacturing facilities, utilities, equipment and supporting systems.
• Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems.
• Maintain and improve FUME quality systems.
• Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), Asset qualification maintenance system strategies and equipment/computer system periodic reviews, as appropriate.
• Conduct gap assessments of global requirements and ensure implementation of the governing standards.
• Maintain and improve FUME quality systems.
• Assist business partners in the interpretation of regulatory and corporate requirements.
• Support the definition and execution of inspection readiness activities as it relates to facility, utilities, equipment, and maintenance.
• Lead project initiatives needed in support of the project and Quality function.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Resolve or escalation of any compliance issues to the project, site, and Quality Management.

Key Objectives/Deliverables

Provide cGMP and Lilly Global Quality Standard expertise working with Global Facility Delivery team, site engineering team, Lilly site staff, and selected firm to support the verification and qualification of site facilities, utilities, and equipment, employing Quality by Design (QBD) and Quality Risk Management principals and ensuring the integration of Global Quality System requirements into the design. Serve as the site subject matter expert for Facility, Utility, Maintenance, and Equipment (FUME) Quality Systems and asset lifecycle compliance. Provide strategic technical leadership for qualification, verification and maintenance of GMP assets. Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures. Provide quality oversight for the verification and qualification of manufacturing facilities, utilities, equipment and supporting systems. Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems. Maintain and improve FUME quality systems. Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), Asset qualification maintenance system strategies and equipment/computer system periodic reviews, as appropriate. Conduct gap assessments of global requirements and ensure implementation of the governing standards. Maintain and improve FUME quality systems. Assist business partners in the interpretation of regulatory and corporate requirements. Support the definition and execution of inspection readiness activities as it relates to facility, utilities, equipment, and maintenance. Lead project initiatives needed in support of the project and Quality function. Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group. Resolve or escalation of any compliance issues to the project, site, and Quality Management.

Basic Qualifications

BS in Engineering or a science-related field or equivalent experience. 8+ years in pharmaceutical quality/engineering with significant FUME quality systems experience and experience supporting API and/or OSD manufacturing operations. Candidates must have current authorisation to work in the European Union.

Skills

Previous experience with Commissioning & Qualification (C&Q) / Verification and Validation oversight including automation and computer systems validation (CSV). Experience in API/drug product manufacturing, Oral Solid Dosage (OSD), QA or Engineering. Must have hands‑on experience with quality engineering related documentation review/approval. Previous experience with capital project delivery. Demonstrated ability to communicate with cross‑functional teams including good oral and written communication skills. Demonstrated strong written and verbal communications skills. Strong attention to detail. Proficiency with computer system applications. Knowledge of cGMPs and quality systems. Understanding of statistical tools and analysis. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks, work under multiple priorities and tight time line. Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs. Experience with Instrument Qualification activities would be advantageous.

On‑site Requirement

This is 100% full‑time on‑site role.

Travel Requirements

We typically expect travel to be 10‑20% during the design and delivery phase for engineering meetings, training, and job shadowing 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) 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is €60,000 - €99,000 Full‑time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).

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

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!