Develop and execute commissioning protocols (FAT, SAT, IQ, OQ, PQ).
Lead qualification of equipment, utilities, and facilities in GMP-regulated environments.
Perform risk assessments and ensure compliance with regulatory standards (FDA, EMA, GAMP, ISPE).
Review system documentation (P&IDs, wiring diagrams) and participate in system walkdowns.
Collaborate with engineering, manufacturing, and quality teams to support installation and commissioning.
5+ years of C&Q experience in Pharmaceuticals, Biotech, or Medical Devices.
Strong knowledge of GMP, FDA, EMA, ISPE, and GAMP regulatory requirements.
Hands-on experience with HVAC, bioreactors, clean utilities, process gases, and environmental monitoring systems.
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