Purpose

Are you a Commissioning & Qualification (C&Q) Engineer with a passion for ensuring GMP compliance, safety, and efficiency in pharmaceutical/biotech projects? We’re looking for a driven professional to lead C&Q activities for clean utilities, facilities, and process equipment in a high-impact capital project!

Responsibilities:

Own C&Q projects—drafting protocols, executing tests (FAT/SAT/IV/FT), and ensuring compliance.
Generate critical C&Q documentation (Plans, Summary Reports, URS, Risk Assessments)
Supervise & coordinate C&Q activities, ensuring schedule adherence and risk mitigation.
Lead daily C&Q meetings, track progress, and report on system readiness.
Ensure safe startup of equipment/utilities while collaborating with cross-functional teams.

Requirements

3+ years in Engineering or C&Q within Pharma/Biotech.
Technical degree in Engineering (or equivalent).
Strong knowledge of GMP, regulatory requirements, and risk-based qualification.
Leadership & communication skills to engage senior stakeholders.
Experience with paperless validation systems is a plus!