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Senior pharmaceutical systems integration specialist

Waterford
beBeeMechanical
Biostatistician
Posted: 1 December
Offer description

Pharmaceutical Commissioning Engineer

We are seeking a skilled Mechanical Engineer to support the Commissioning, Qualification, and Verification (CQV) efforts for the installation and integration of heat pump equipment and two boiler equipment packages on a GMP pharmaceutical manufacturing site.

This is a 12-month contracting position. You will lead and support CQV activities for heat pump and boiler systems, including:

1. Design Qualification (DQ) review
2. Commissioning protocol generation and execution (FAT, SAT)
3. Verification of mechanical installation (piping, pumps, exchangers, valves)
4. System walkdowns and punch list resolution
5. Review and approval of P&IDs, datasheets, isometrics, and turnover packages
Engineering Implementation
6. Review and contribute to the design and layout of mechanical systems
7. Oversee vendor equipment delivery, installation, and field verification
8. Interface with building management systems (BMS/EMS) for control and monitoring setup
9. Support tie-in and integration planning with existing utility networks (steam, hotwater, chilled water, etc.)
10. Documentation & Compliance
11. Generate and review engineering and CQV documentation per site GMP standards,including:
Mechanical Completion documentation
12. Utility Impact Assessments
13. Risk assessments and URS traceability
14. Turnover package compilation and support handover to Operations
15. Cross-functional Collaboration
16. Liaise with project teams, contractors, vendors, validation, and QA to ensure mechanical systems are installed and qualified per cGMP and safety requirements
17. Participate in project and CQV meetings, tracking action items to resolutions

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