Proclinical is seeking a Mechanical Engineer to support Commissioning, Qualification, and Verification (CQV) activities for the installation and integration of heat pump and boiler equipment packages at a GMP pharmaceutical manufacturing site. This role involves close collaboration with cross-functional teams to deliver qualified utility systems supporting production, packaging, warehousing, and ancillary spaces.
This is a 12-month contract role based 100% onsite in Waterford, Ireland. Candidates must have the right to work in the Republic of Ireland.
Responsibilities:
- Lead and support CQV activities for heat pump and boiler systems, including:
- Design Qualification (DQ) reviews.
- Commissioning protocol generation and execution (FAT/SAT).
- Verification of mechanical installations (piping, pumps, exchangers, valves).
- System walkdowns and punch list resolution.
- Review and approval of P&IDs, datasheets, isometrics, and turnover packages.
- Contribute to the design and layout of mechanical systems.
- Oversee vendor equipment delivery, installation, and field verification.
- Interface with building management systems (BMS/EMS) for control and monitoring setup.
- Support tie-in and integration planning with existing utility networks (e.g., steam, hot water, chilled water).
- Generate and review engineering and CQV documentation per GMP standards, including:
- Mechanical Completion documentation.
- Utility Impact Assessments.
- Risk assessments and URS traceability.
- Turnover package compilation and handover to Operations.
- Collaborate with project teams, contractors, vendors, validation, and QA to ensure compliance with cGMP and safety requirements.
- Participate in project and CQV meetings, tracking action items to resolution.
Key Skills and Requirements:
- Background in Mechanical Engineering or a related discipline.
- Experience in mechanical systems implementation within pharmaceutical or biotech facilities.
- Familiarity with CQV processes for utility systems, including boilers, heat pumps, HVAC, and chilled/hot water systems.
- Strong understanding of GMPs and GEP.
- Knowledge of relevant mechanical and utilities standards (e.g., ASME B31.3, PED).
- Proficiency in reading and redlining P&IDs, isometrics, and mechanical schematics.
- Excellent problem-solving, communication, and technical writing skills.
- Desirable: Experience with green or energy-efficient technology integration (e.g., heat pumps).
If you are having difficulty in applying or if you have any questions, please contact Numhom Sudsok at n.sudsok@proclinical.com.
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