C&Q Turnover Engineer

EPM Scientific are partnered with a key client of ours who are servicing a Pharmaceutical project in the West of Frankfurt and we are seeking an experienced C&Q Turnover Engineer to join them on a long term assignment.

• Compile Turnover Documentation (CTOP): Strong Liaison with Construction management team to ensure that CTOP documentation is fit for purpose and dossiers contain the correct documentation for leveraging into IV Protocol.
• Document Generation: Using KNEAT, generate IV/OV Commissioning Test Plans (CTP). External to KNEAT, generate a system based Test Matrix(TM) and update associated Risk Assessments.
• Field Execution: Attend W2 walkdowns and witness slope verification checks. Hands-on execution of IV/OV protocols in the field. Provide SAT support to vendors.
• Punchlist Closeout: Investigate non-conformances during testing. Log punch list items in DocuTools and raise documentation issues within the KNEAT Protocol.
• System Walkdowns: Perform physical inspections, P&ID walkdowns, and ATEX compliance checks.
• Vendor Coordination: Review vendor turnover packages (VTOP) and align factory testing with site protocols.

• API Equipment: Demonstrate knowledge of reactors, centrifuges, dryers, pack off equipment, mobile lifting columns and media panels.
• Automation Platform: Direct experience testing loops, graphics, and interlocks within a DCS system.
• Hazardous Areas: Strong understanding of ATEX directives, explosion protection documents (EPD), and intrinsically safe instrumentation.
• Clean Utilities: Experience - purified water, solvent distribution, process air, vacuum systems, process gases, thermal oil, breathing air, solvent waste.
• Black Utilities: chilled water, steam and industrial HVAC systems.
• Regulations: Strong working knowledge of ASTME 2500, FDA, EMA, ICH Q7, and ISPE Baseline Guides.

• Education: Bachelor's degree in chemical / mechanical Engineering.
• Experience: Minimum 10 years of direct CQ experience in a GMP environment (API preferred).
• Physical: Ability to work on-site, gown up for cleanrooms, and safely navigate hazardous/classified environments.
• English spoken in the project team, commissioning documentation in English. Lots of the trade partners and vendors are strictly German speakers.
• The key objective is to understand the construction management, quality checks, TOPs and integration of systems as well as possible to be successful in the role(s).