Senior/Sr. Principal Automation Engineer, Quality Assurance

About the role

Eli Lilly is hiring a Senior/Sr. Principal Automation Engineer for Quality Assurance at its Katwijk site, where a new €2.6 billion manufacturing facility producing oral medicines for cardiometabolic health, neuroscience, oncology and immunology is being built. The position starts with a 12-month contract, with the intention of offering a permanent contract based on mutual fit.

The engineer acts as the site subject matter expert for Computer System Validation (CSV), automation compliance and data integrity for GMP computerized systems such as DCS, SCADA, MES, Historians and building management systems, and leads the validation, maintenance and lifecycle management of these systems for Oral Solid Dose manufacturing.

Key responsibilities

• Establish and maintain CSQ support and data integrity sustainability processes, and drive consistency in CSQ and DI controls.
• Serve as the site CSV SME for automation systems and lead site CSV strategies and governance models through design, implementation, qualification, operation and retirement.
• Partner with Automation, Engineering, Quality and Tech@Lilly teams to ensure GMP compliance, data integrity and maintenance of validated systems, and support commissioning, qualification and validation of automated manufacturing systems.
• Mentor colleagues in DI and CSV, and provide cross-functional technical leadership during serious quality-related incidents.
• Monitor inspection readiness, consult on corporate standards, and promote common processes and continuous improvement.

Required profile

• Bachelor's degree in Computer Science, Engineering, Mathematics, Life Sciences or a related field.
• Minimum of 10+ years of experience in pharmaceutical automation, CSV, QA, engineering or related GMP environments.
• Experience supporting API and/or Oral Solid Dose manufacturing, and with automation platforms and computerized system lifecycle management.
• Current authorization to work in the European Union.
• Preferred: direct GAMP5 and ALCOA+ experience, GMP/GLP background, Six Sigma, and experience leading cross-functional CSV initiatives.

Required skills

• DCS, SCADA, MES, Historians, PLCs and building management systems.
• GAMP5, data integrity (ALCOA+) and computerized system lifecycle management.
• Commissioning, qualification and validation of automation systems in greenfield facilities.

What we offer

• Anticipated wage depending on education, experience, skills and location; full-time equivalent employees may be eligible for a company bonus.
• Benefits including pension plan, vacation, healthcare, flexible benefits, life insurance, time off and well-being benefits.