Senior Mechanical Systems Specialist

3 days ago

Waterford, Waterford, Ireland beBeeMechanical Full time €60,000 - €80,000
CQV Engineer Job Description

We are seeking a highly skilled Mechanical Engineer to support our CQV activities for the installation and integration of heat pump equipment and two boiler packages onsite.

The ideal candidate will collaborate closely with project engineering, CQV, quality assurance, and operations teams to deliver qualified utility systems that meet GMP standards.

  • Lead and support CQV activities for heat pump and boiler systems.
  • Design Qualification (DQ) review.
  • Commissioning protocol generation and execution.
  • Verification of mechanical installation.
  • 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.
  • 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 handover to Operations.
  • Liaise with project teams, contractors, vendors, validation, and QA to ensure mechanical systems are installed and qualified per c GMP and safety requirements.

This project-based role involves working on an active GMP site with potential for shift or weekend work during key CQV phases. The ideal candidate will interface with construction, startup, and operational environments and may require field work including equipment inspections and system verifications.

Requirements:

  • Bachelors 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 desirable.
  • Ability to read and redline P&IDs, isometrics, and mechanical schematics desirable.

The successful candidate will possess a strong understanding of site utility systems and their impact on GMP manufacturing.

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