Senior Principal Engineer, FUME Quality & Compliance

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

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.