Engineer Commissioning, Qualification & Validation (CQV)
Core
Execute and coordinate Installation, Operational, and Performance qualification (IQ/OQ/PQ) activities for analytical instruments, equipment, utilities, and facilities systems within a cell therapy environment.
Role type
CQV Engineer (Commissioning, Qualification & Validation)
Builds
Validated pharmaceutical manufacturing and laboratory systems for cell therapy production.
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GXP/GAMP knowledge, 21CFR part 11 compliance, EU GMP Annex 15, analytical instrument qualification, technical writing, data recording per GDP, calibration management, cross-functional collaboration
Preferred skills
BS in Engineering or Science, 1-3 years pharmaceutical validation experience, familiarity with SDLC regulations
Technologies
Analytical instruments, utilities, facility systems, computer systems validation tools
Responsibilities
Write and execute validation protocols, create final qualification reports, ensure documentation accuracy and GDP compliance, coordinate requalification activities, interface with customers and multi-functional teams, maintain safe working environment
Seniority
Mid-level IC (1-3 years experience)
