Life Sciences Computer system validation engineer
Core
Ensure GxP systems and processes comply with regulatory requirements throughout their lifecycle in the Life Sciences sector.
Role type
Computer System Validation (CSV) Engineer
Builds
Validated GxP systems for Life Sciences clients
Domain
Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Computer System Validation (CSV), GxP regulations (GLP, GCP, GMP, GDP, GPvP), 21 CFR Part 11, EU Annex 11, GAMP5, ISO 9001, QMS, CAPA, data integrity, Waterfall/Agile methodologies, IT infrastructure qualification
Preferred skills
Analytical mindset, prioritization, solution-oriented attitude, team collaboration, autonomous work
Technologies
HPLC software, capsule filling machines, clinical trial systems, Manufacturing Execution Systems (MES), SAP, medical devices
Responsibilities
Monitor GxP system and process compliance, stay updated on EMA/FDA regulations and industry standards, support audits and inspections, validate GxP systems across various domains
Seniority
Mid-level, hands-on IC