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).
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