CQV Engineer (Mechanical)
- Waterford
- Contract
- Full-time
A biopharmaceutical company in Waterford is seeking an experienced Mechanical Engineer to support CQV activities for the installation and integration of heat pump equipment and two boiler packages onsite. The successful candidate will collaborate closely with project engineering, CQV, quality assurance, and operations teams, with a focus on delivering qualified utility systems to support four main operational areas (production, fill-finish, packaging, and warehousing) as well as ancillary spaces (such as laboratories, maintenance, and utility buildings).Responsibilities:
- Lead and support CQV activities for heat pump and boiler systems.
- 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.
- Review and approval of P&IDs, datasheets, isometrics, and turnover packages.
- Review and 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 (steam, hot water, chilled water, etc.).
- Generate and review engineering and CQV documentation per site GMP standards.
- Mechanical Completion documentation.
- Utility Impact Assessments.
- Risk assessments and URS traceability.
- Turnover package compilation and support handover to Operations.
- 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, tracking action items to resolution.
- Project-based role on an active GMP site with potential for shift or weekend work during key CQV phases.
- Interface with construction, startup, and operational environments.
- May require field work including equipment inspections and system verifications.
- 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 (preferably boilers, heat pumps, HVAC, chilled/hot water).
- Strong understanding of GMPs, GEP.
- Familiarity with ASME B31.3, PED, and relevant mechanical/utilities standards.
- Previous experience with green or energy-efficient technology integration (e.g., heat pumps) desirable.
- Ability to read and redline P&IDs, isometrics, and mechanical schematics desirable.
- Understanding of site utility systems and their impact on GMP manufacturing desirable.