CQV Engineer
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2025-12-22
Listing for:
Shoolin Inc
Full Time
position Listed on 2025-12-22
Job specializations:
-
Engineering
Quality Engineering, Pharma Engineer, Process Engineer, Validation Engineer -
Pharmaceutical
Quality Engineering, Pharma Engineer, Validation Engineer
Job Description & How to Apply Below
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)
- 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.
Mid-Senior level
Employment typeContract
Job functionPharmaceutical Manufacturing
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