CQV Engineer
Shoolin
CQV Engineer Seeking an experienced Pharmaceutical Commissioning Engineer to lead commissioning activities for critical utility systems in a GMP-regulated pharmaceutical environment. The role focuses on risk-based commissioning, quality compliance, and delivery of fully documented, compliant utility systems. Required Experience 3+ years of pharmaceutical commissioning experience Hands-on commissioning of critical utility systems (WFI, Clean Steam, HVAC, Autoclaves) Strong GMP and Pharmaceutical Quality System knowledge Experience with Quality Risk Management (QRM) and risk assessments Working knowledge of ASTM E2500 (risk-based commissioning/qualification) Bachelor’s degree in Engineering (Mechanical, Chemical, or Process) Key Responsibilities Lead commissioning of non-impact and impact utility systems, including industrial water, sanitary waste, refrigerated water, WFI generation and distribution, clean steam, autoclaves, and cleanroom HVAC (Grade B & C). Ensure all commissioning activities comply with GMP and Pharmaceutical Quality System requirements. Develop and execute QRM deliverables, including risk assessments and mitigation strategies. Prepare, review, and approve commissioning protocols, documentation, and final reports. Collaborate with cross-functional teams to support timely project execution and system handover. Seniority level Mid-Senior level Employment type Contract Job function Pharmaceutical Manufacturing #J-18808-Ljbffr
Vacancy posted 3 days ago
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