Life Sciences Computer System Validation Engineer
Core
Ensuring GxP systems and processes comply with legal requirements throughout their lifecycle for Life Sciences clients.
Role type
Computer System Validation (CSV) Engineer
Builds
Validated automated systems including lab instruments, production equipment, web apps, and clinical/manufacturing software.
Domain
Life Sciences / Regulatory Compliance / IT Validation
Deliverable
production ML models | product features | infrastructure
Required skills
Computerized System Validation (CSV) experience, knowledge of GxP regulations (GLP, GCP, GMP, GDP, GPvP), familiarity with 21CFR Part 11 and EU Annex 11, knowledge of GAMP5 and ISO standards, understanding of QMS and CAPA concepts, validation methodology expertise (Waterfall, Agile), analytical thinking, prioritization and planning, written and verbal communication in Dutch and English, basic IT infrastructure knowledge.
Preferred skills
Experience in Quality & Compliance support during audits and inspections, ability to work independently within a team.
Technologies
HPLC software, capsule-filling machines, Clinical Trial Management Systems, Manufacturing Execution Systems, SAP systems, medical devices.
Responsibilities
Monitor changing regulations from EMA and FDA, ensure quality and regulatory compliance of GxP systems across all GxP areas, support audits and inspections, participate in validation teams.
Seniority
Mid-level, hands-on IC