At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
About the Katwijk Site
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.
Position Overview
The Sr Director, Process, Maintenance & Automation Engineering provides strategic and operational leadership for Process Engineering, Automation, and Maintenance functions at the Katwijk site. This role ensures the reliability, compliance, and continuous performance of manufacturing equipment, control systems, and automated technologies. As a member of the Site Leadership Team, the incumbent will champion next-generation manufacturing capabilities — including paperless operations, dock-to-dock automation, and process analytical technology — while delivering a world-class, GMP-compliant maintenance programme from site startup through steady-state operations.
Key Responsibilities
Leadership & People Management
- Develop vision and operational discipline across Process Engineering, Automation, and Maintenance functions in accordance with Eli Lilly Manufacturing Standards.
- Provide supervisory direction for department leaders, employees, and contractors across all supported functions.
- Conduct performance appraisals, salary reviews, and HRP sessions; develop talent assessment, career, and succession plans.
- Foster a culture of technical excellence, safety, and continuous improvement.
Process Engineering
- Ensure regulatory compliance from an equipment, instrumentation, and process performance perspective.
- Provide technical leadership for troubleshooting, deviation resolution, change management, safety assessments, and lifecycle management of manufacturing processes.
- Drive initiatives that improve process efficiency, compliance, and productivity.
- Coordinate engineering support for manufacturing operations and daily activities.
Automation & Technology
- Implement and manage automated systems and technologies, including dock-to-dock automation, paperless manufacturing, and process analytical technology (PAT).
- Ensure compliance with Computer Systems Validation (CSV), Infrastructure Platform Qualification, and Software Quality practices.
- Ensure compliance with FDA regulations including 21 CFR Part 11 and applicable computer systems regulations.
- Oversee the lifecycle management of automation platforms, control systems, and digital manufacturing tools.
Maintenance Programme
- Oversee the development, implementation, and execution of a comprehensive maintenance programme encompassing preventive, corrective, and predictive maintenance, as well as planning and scheduling.
- Oversee technical maintenance services including pressure vessels, spare parts, CMMS, mechanical integrity, calibration, and reliability services.
- Ensure adequate lifecycle management of plant assets and equipment.
- Coordinate and allocate resources for daily maintenance operations and projects.
Financial Management
- Develop and manage annual expense and capital budgets for Process Engineering, Automation, and Maintenance departments.
- Control expenses and capital expenditures; ensure monthly and annual financial reporting and forecasting is timely and accurate.
- Supervise monthly reporting of departmental performance metrics.
Quality, Compliance & EHS
- Ensure all operations comply with Good Manufacturing Practices (GMP), Good Documentation Practices, and applicable regulatory requirements.
- Ensure compliance with EHS regulatory agencies and Eli Lilly EHS Corporate Policies; integrate EHS requirements into business planning.
- Model desired safety culture through actions and decisions; conduct regular management audits of areas.
- Establish and monitor metrics for inspections, training, and incidents.
- Ensure thorough, accurate, and up-to-date training for all employees and contractors.
Qualifications & Requirements
Education
- Bachelor's degree in Engineering (Chemical, Electrical, Mechanical, or equivalent).
- Ideally bilingual — English and Dutch preferred.
Experience
- 10+ years of experience in engineering-related fields.
- 7+ years in manufacturing, preferably in pharmaceutical or other regulated industries.
- Demonstrated experience in process engineering, automation systems, and maintenance management in a GMP-regulated environment.
Technical Knowledge
- Knowledge of pharmaceutical regulations including cGMPs, 21 CFR Part 11, and FDA Computer Systems regulations.
- Knowledge of Computer Systems Validation (CSV), Infrastructure Platform Qualification, and Software Quality practices.
- Knowledge of System Lifecycle management, software engineering, design principles, and infrastructure operations.
- Knowledge of process safety management principles.
- Familiarity with CMMS platforms and reliability-centred maintenance methodologies.
Leadership & Interpersonal Skills
- Effective leadership, teamwork, interpersonal, and communication skills.
- Excellent technical writing, negotiation, and presentation capabilities.
- Ability to work with minimal supervision, manage competing priorities, and drive results in a fast-paced, evolving environment.
- Strong decision-making, problem-solving, and organisational skills.
- Ability to influence and develop others; self-starter with strong self-management skills.
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.
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