Senior Automation & CSV Leader (GMP/data integrity)

Eli Lilly and Company

Katwijk

On-site

EUR 60,000 - 99,000

Full time

12 days ago

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Job summary

Lilly's Katwijk site seeks a Senior/Sr. Principal Automation Engineer - Quality Assurance to own CSV and data integrity for GMP systems (DCS, SCADA, MES, Historians, Building Management Systems) across the OSD manufacturing operations.

You will define and drive validation strategies, lifecycle management, and compliance with corporate standards while partnering with Automation, Engineering, Quality and Tech@Lilly teams to sustain validated states and ensure inspection readiness.

Qualifications

Bachelor’s degree in Computer Science, Engineering, Mathematics, Life Sciences, or a technology-related field.
Minimum of 10+ years in pharmaceutical automation, CSV, QA, engineering, or GMP-regulated environments.
Experience supporting API and/or Oral Solid Dose (OSD) manufacturing operations.
Experience with automation platforms, manufacturing control systems, and lifecycle management.
EU work authorization is required.

Responsibilities

Lead CSV processes and data integrity sustainability for GMP systems.
Serve as site SME for automation validation (DCS, SCADA, MES, Historians, BMS).
Provide strategic leadership for CSV activities across design, qualification, operation and retirement.
Develop and implement site CSV strategies and governance models.
Partner with Automation, Engineering, Quality and Tech@Lilly teams to ensure compliance.
Support commissioning, qualification and validation activities for automated systems.