Overview
Mechanical Engineer responsible for supporting Commissioning, Qualification, and Verification (CQV) efforts for the installation and integration of heat pump equipment and boiler packages on a GMP pharmaceutical manufacturing site. The role collaborates with project engineering, CQV, quality assurance, and operations teams to deliver qualified utility systems for production, fill-finish, packaging, warehousing, and ancillary spaces (labs, maintenance, and utility buildings).
Responsibilities
* CQV & Project Support: Lead and support CQV activities for heat pump and boiler systems, including Design Qualification (DQ) review, commissioning protocol generation and execution (FAT, SAT), verification of mechanical installation (piping, pumps, exchangers, valves), system walkdowns and punch list resolution, and review/approval of P&IDs, datasheets, isometrics, and turnover packages.
* Engineering Implementation: Review and contribute to the design and layout of mechanical systems; oversee vendor equipment delivery, installation, and field verification; interface with building management systems (Client/EMS) for control and monitoring setup; support tie-in and integration planning with existing utility networks (steam, hot water, chilled water, etc.).
* Documentation & Compliance: Generate and review engineering and CQV documentation per site GMP standards, including Mechanical Completion documentation, Utility Impact Assessments, risk assessments and URS traceability, and turnover package compilation and handover to Operations.
* Cross-functional Collaboration: Liaise with project teams, contractors, vendors, validation, and QA to ensure mechanical systems are installed and qualified per cGMP and safety requirements; participate in project and CQV meetings and track action items to resolution.
Qualifications
* Bachelor's degree in Mechanical Engineering or related discipline
* 5+ years of experience in mechanical systems implementation on pharmaceutical/biotech facilities
* Experience in CQV for utility systems (boilers, heat pumps, HVAC, chilled/hot water)
* Strong understanding of GMPs, GEP; familiarity with ASME B31.3, PED, and relevant mechanical/utilities standards
* Excellent problem-solving, communication, and technical writing skills
* Previous experience with green or energy-efficient technology integration (e.g., heat pumps)
* Ability to read and redline P&IDs, isometrics, and mechanical schematics
* Understanding of site utility systems and their impact on GMP manufacturing work environments
* Project-based role on an active GMP site with potential for weekend work during key CQV phases
* Interface with construction, startup, and operational environments; may require field work including equipment inspections and system verifications
Employment type
* Contract
Job function
* Engineering and Quality Assurance
* Industries: Pharmaceutical Manufacturing
Location
Waterford, County Waterford, Ireland
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