Senior GMP Automation & CSV Lead
436 Eli Lilly Nederland B.V.
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Benefits offered by this job
Job summary
Eli Lilly Nederland B.V. in Katwijk seeks a Senior/Sr. Principal Automation Engineer – Quality Assurance to lead validation and data integrity for GMP computerized systems in OSD manufacturing.
You will define validation strategies, govern lifecycle management, and ensure compliance across DCS, SCADA, MES, historians and related automation platforms. The role requires deep CSV expertise, ALCOA+ data integrity, and strong cross‑functional leadership to sustain inspection readiness and drive
Qualifications
- Bachelor's degree in a technology-related field.
- 10+ years in pharmaceutical automation/CSV/GMP environments.
- Experience with API/OSD manufacturing operations.
- Experience with automation platforms and lifecycle management.
- EU work authorization.
Responsibilities
- Lead CSV processes and data integrity sustainability.
- Provide site CSV governance for automation systems throughout design, implementation, qualification, operation and retirement.
- Mentor others in DI and CSV-related roles.
- Maintain inspection readiness and escalate issues as needed.
- Promote best practices and drive continuous improvement across functions.
Skills
Education
Tools
Job description
Eli Lilly Nederland B.V. in Katwijk seeks a Senior/Sr. Principal Automation Engineer – Quality Assurance to lead validation and data integrity for GMP computerized systems in OSD manufacturing.
You will define validation strategies, govern lifecycle management, and ensure compliance across DCS, SCADA, MES, historians and related automation platforms. The role requires deep CSV expertise, ALCOA+ data integrity, and strong cross‑functional leadership to sustain inspection readiness and drive
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