Senior/Sr. Principal Engineer, Quality Assurance

About the role

Eli Lilly is hiring a Senior/Sr. Principal Engineer, Quality Assurance for its Katwijk site, where a €2.6 billion new manufacturing facility for oral medicines in cardiometabolic health, neuroscience, oncology and immunology is being built. The role provides guidance, consultation and oversight across the design, verification, startup and ongoing life cycle of site facilities, utilities and equipment, ensuring cGMP compliance. It starts with a 12-month contract, with the intention of a permanent contract based on mutual fit, and is a 100% full-time on-site position.

Key responsibilities

• Provide cGMP and Lilly Global Quality Standard expertise with the Global Facility Delivery team, site engineering team and site staff to verify and qualify facilities, utilities and equipment using Quality by Design and Quality Risk Management.
• Act as site subject matter expert for Facility, Utility, Maintenance and Equipment (FUME) quality systems and asset lifecycle compliance.
• Review and approve project documents and provide quality oversight of verification and qualification of manufacturing assets.
• Mentor engineering and QA teams, maintain and improve FUME quality systems, and contribute to Annual Product Reviews, quarterly self-assessments and equipment periodic reviews.
• Conduct gap assessments of global requirements, support inspection readiness and resolve or escalate compliance issues.
• Lead project initiatives for the Quality function and foster a strong quality culture.

Required profile

• BS in Engineering or a science-related field, or equivalent experience.
• 8+ years in pharmaceutical quality or engineering with significant FUME quality systems experience and API and/or OSD manufacturing support.
• Current authorisation to work in the European Union.
• Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs; capital project delivery experience.

Required skills

• Commissioning and Qualification (C&Q) and verification/validation oversight, including CSV.
• Hands-on experience reviewing and approving quality engineering documentation.
• Knowledge of cGMPs and quality systems, understanding of statistical tools.
• Strong written and verbal communication, attention to detail and ability to prioritise under tight deadlines.

Travel of about 10-20% is expected during design and delivery. Full-time equivalent employees may be eligible for a company bonus, and Lilly offers a benefit programme including pension, vacation, healthcare, flexible benefits, life insurance and well-being benefits.