CQV Mechanical Engineer

Description

• Participate in project and CQV meetings, tracking action items to resolution
• Generate and review engineering and CQV documentation per site GMP standards, including:
• Commissioning protocol generation and execution (FAT, SAT,)
• Review and approval of P&IDs, datasheets, isometrics, and turnover packages
• May require field work including equipment inspections and system verification
• Oversee vendor equipment delivery, installation, and field verification
• Support tie-in and integration planning with existing utility networks (steam, hot water, chilled water, etc.)
• Lead and support CQV activities for heat pump and boiler systems, including:
• Verification of mechanical installation (piping, pumps, exchangers, valves)
• Interface with construction, startup, and operational environments
• Liaise with project teams, contractors, vendors, validation, and QA to ensure mechanical systems are installed and qualified per cGMP and safety requirement
• The role will involve close collaboration with project engineering, CQV, quality assurance, and operations teams, focusing on delivering qualified utility systems to support four main operational areas (e.g., production, fill-finish, packaging, warehousing) and ancillary spaces (e.g., labs, maintenance, and utility buildings).
• Review and contribute to the design and layout of mechanical systems
• Interface with building management systems (BMS/EMS) for control and monitoring setup
• Turnover package compilation and support handover to Operations

Requirements

• 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)
• Risk assessments and URS traceability
• Excellent problem-solving, communication, and technical writing skills
• Familiarity with ASME B31.3, PED, and relevant mechanical/utilities standards
• Bachelor’s degree in Mechanical Engineering or related discipline
• Understanding of site utility systems and their impact on GMP manufacturing an advantage.
• Mechanical Completion documentation
• Strong understanding of GMPs, GEP,
• Previous experience with green or energy-efficient technology integration (e.g., heat
• Design Qualification (DQ) review
• System walkdowns and punch list resolution
• Ability to read and redline P&IDs, isometrics, and mechanical schematics an advantage
• We are seeking an experienced Mechanical Engineer to support the Commissioning, Qualification, and Verification (CQV) efforts for the installation and integration of heat pump equipment and two boiler equipment packages on our clients GMP pharmaceutical manufacturing site based in County Waterford.

Benefits

• Project-based role on an active GMP site with potential for weekend work during key CQV phases

Training + Development

Interview process

Visa Sponsorship

Security clearance