Commissioning, Qualification, and Validation (CQV) Engineer
Core
Commissioning, qualification, and validation (CQV) engineer supporting pharmaceutical and biotechnology clients by writing and executing protocols, performing field verification, and maintaining records for utilities, equipment, and facilities.
Role type
Mid-level hands-on IC CQV engineer
Builds
Qualification packages (IQ, OQ, PQ) for utilities, equipment, and facilities
Domain
Pharmaceutical and biotechnology manufacturing
Required skills
GMP experience, IQ/OQ/PQ knowledge, technical writing, reading P&IDs, cGMP familiarity (21 CFR 210/211), methodical documentation
Preferred skills
Engineering or life science degree, utilities experience, environmental monitoring, cleanroom experience, risk assessment (ICH Q9/FMEA), electronic validation (GAMP 5)
Technologies
P&IDs, Kneat, LIMS, MODA
Responsibilities
Author and execute commissioning and qualification protocols; Perform field verification and walkdowns against P&IDs; Execute qualification sampling programs and maintain records; Write deviation and summary reports; Support risk assessments and FMEAs; Support change control and close out qualification packages
Seniority
Mid-level, hands-on IC
