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Mechanical Engineer
2 weeks ago
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).