CQ / Turnover Engineer

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.