Validation Engineer
Core
Execute qualification and validation activities for equipment, systems, facilities, and processes in a regulated manufacturing and laboratory environment.
Role type
Validation Engineer (Regulated Environment)
Builds
Qualified equipment, systems, and processes for life science and diagnostic technology manufacturing
Domain
Life Sciences / Diagnostics / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification, Process validation, IQ/OQ/PQ protocols, GMP compliance, Deviation investigation, CAPA implementation, Technical documentation, Risk assessment, Cross-functional coordination, Cleanroom operations
Preferred skills
GAMP5 knowledge, ISO/FDA regulations, Quality management systems, Calibration, Metrology, Statistical analysis, Gap analysis, Contractor coordination
Technologies
Microsoft Office
Responsibilities
Plan and execute qualification activities, Prepare and review IQ/OQ/PQ protocols, Investigate discrepancies and deviations, Define corrective actions, Coordinate technicians and contractors, Support validation documentation improvements
Seniority
Mid-level, hands-on IC
