Senior Director - Process, Maintenance & Automation Engineering

About the role

Eli Lilly is investing €2.6 billion in a new manufacturing facility in Katwijk, Netherlands, producing oral medicines for cardiometabolic health, neuroscience, oncology and immunology. The Senior Director, Process, Maintenance & Automation Engineering leads Process Engineering, Automation and Maintenance at the Katwijk site and sits on the Site Leadership Team. The role ensures the reliability, compliance and continuous performance of manufacturing equipment, control systems and automated technologies, and delivers a GMP-compliant maintenance programme from site startup through steady-state operations.

Key responsibilities

• Lead Process Engineering, Automation and Maintenance, set departmental vision and supervise department heads, employees and contractors, including performance appraisals, salary reviews and succession planning
• Ensure regulatory compliance of equipment, instrumentation and processes, and lead troubleshooting, deviations, change management and safety assessments
• Manage automated systems such as dock-to-dock automation, paperless manufacturing and PAT, including CSV, 21 CFR Part 11 and lifecycle management of automation platforms
• Run a maintenance programme covering preventive, corrective and predictive maintenance, pressure vessels, spare parts, CMMS, mechanical integrity, calibration and reliability
• Manage annual expense and capital budgets, monthly reporting and forecasting, and departmental performance metrics
• Ensure GMP, GDDP and EHS compliance, run management audits and keep training up to date

Required profile

• Bachelor's degree in Chemical, Electrical or Mechanical Engineering (or equivalent)
• 10+ years of engineering experience, 7+ in manufacturing, preferably in pharmaceutical or regulated industries
• Demonstrated experience in process engineering, automation systems and maintenance management in a GMP environment
• Ideally bilingual English and Dutch

Required skills

• cGMP, 21 CFR Part 11 and FDA computer systems regulations
• Computer Systems Validation, Infrastructure Platform Qualification and Software Quality
• System lifecycle management, process safety management
• Familiarity with CMMS platforms and reliability-centred maintenance
• Technical writing, negotiation and presentation skills

Full-time equivalent employees may be eligible for a company bonus depending on performance, and a comprehensive benefits package including pension, healthcare and flexible benefits is offered.