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
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