At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
About the Katwijk Site
This position starts with a 12-month contract, with the intention of offering a permanent contract based on mutual fit. (Dienstverband: tijdelijk met uitzicht op vast)
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 Description
The Senior/Sr. Principal Automation Engineer - Quality Assurance serves as the site subject matter expert for Computer System Validation (CSV), automation compliance, and data integrity for GMP computerized systems including DCS, SCADA, MES, Historians, Building Management Systems and supporting automation platforms.
This role provides strategic leadership for the validation, maintenance, and lifecycle management of GMP computerized and automation systems supporting Oral Solid Dose (OSD) manufacturing operations at the Katwijk site.
In addition, this role is also responsible for the definition, implementation, and maintenance of data integrity controls in GMP regulated computer systems. This includes working with Automation, QC labs, and Tech@Lilly persons to develop validation strategies for the approach to computer system validation in compliance with corporate standards; consultation and interpretation on applying and right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in internal and external Regulatory agency inspections; conducting evaluations of internal or supplier quality practices; maintenance of inspectional readiness; and external benchmarking of computer system validation practices. Finally, this position will leverage an understanding of GMP data flows (electronic and paper), the application of data management/integrity principles in the site's processes, and validation/maintenance requirements to support regulatory compliance, consistency, and sustainment.
Responsibilities
Deliver on CSV Processes and Data Integrity Sustainability
Establish and maintain CSQ support and DI sustainability processes.
Drive appropriate consistency in CSQ and DI controls.
Deliver Projects and Programs
Serve as the site subject matter expert for automation system validation including DCS, SCADA, MES, Historian, Building Management Systems and other GMP computerized systems.
Provide strategic leadership for CSV activities associated with automation systems throughout design, implementation, qualification, operation and retirement.
Lead the development and implementation of site CSV strategies and governance models to ensure the ongoing validated state of GMP computerized systems throughout their lifecycle.
Partner with Automation, Engineering, Quality and Tech@Lilly teams to ensure GMP compliance, data integrity and maintenance of validated automation systems.
Support commissioning, qualification and validation activities for automated manufacturing systems and equipment.
Grow Capabilities and Knowledge
Mentor others in DI and CSV-related roles.
Grow capabilities of those performing DI CSV…