CQ / Turnover Engineer
CQV / Turnover Engineer (Germany) | Freelance Contract
We are seeking an experienced CQV / Turnover Engineer to support a major API manufacturing project in Germany. This is a hands-on, site-based role focused on commissioning, qualification, and turnover activities across process equipment, utilities, automation systems, and hazardous area installations within a GMP-regulated environment.
Key Responsibilities
- Compile and review turnover packages (CTOP) alongside construction and project teams.
- Generate IV/OV protocols, test matrices, and risk assessments using KNEAT.
- Execute field commissioning and qualification activities, including walkdowns, testing, and SAT support.
- Investigate deviations, manage punch list items, and support documentation closeout.
- Perform system inspections, P&ID walkdowns, and ATEX compliance assessments.
- Review vendor turnover documentation and ensure alignment with site qualification standards.
Essential Experience
- Significant CQV / Turnover experience within pharmaceutical, biotech, or API manufacturing environments.
- Strong knowledge of API process equipment, including reactors, centrifuges, dryers, and pack-off systems.
- Experience with clean utilities (PW, process air, vacuum, gases, solvent systems) and black utilities (steam, chilled water, HVAC).
- Hands-on experience testing DCS systems, including loops, interlocks, and graphics.
- Strong understanding of ATEX regulations, hazardous area installations, and intrinsically safe instrumentation.
- Working knowledge of ASTM E2500, FDA, EMA, ICH Q7, and ISPE guidance.
- Experience using KNEAT is highly desirable.
Requirements
- Bachelor's Degree in Engineering or related discipline.
- Minimum 10 years of CQV experience within GMP-regulated pharmaceutical environments.
- Previous API project experience strongly preferred.
- Comfortable working on-site within operational manufacturing and classified environments.
Location: Germany (On-site)
Contract Type: Freelance / Contract
Start: ASAP
An excellent opportunity to join a high-profile API project and play a key role in the delivery and qualification of critical manufacturing systems.
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