CQV Engineer - Grey Utilities (HVAC) for Pharma

HRM Search Partners; Limerick; On-site; EUR 85,000 - 115,000; Full time

Job summary

HRM Search Partners seeks a CQV Engineer - Grey Utilities for a pharmaceutical environment in Ireland. You will lead commissioning, qualification and validation activities for grey utility systems, ensuring cGMP compliance and timely project deliverables.

Plan and execute CQV protocols (URS, FAT, SAT, DQ, IQ, OQ) and review design docs (P&IDs, datasheets). Coordinate with engineering, automation, production and quality teams to drive smooth start-up and post-commissioning support.

Qualifications

• Minimum 5 years in CQV roles with a focus on grey utilities in pharmaceutical or related regulated industry.
• In-depth knowledge of grey utility systems: HVAC, clean/plant utilities, air handling, compressed air, steam, chilled water, cooling towers, non-process water, etc.
• Familiarity with GEP, cGMP, FDA, EMA, ISPE Baseline Guides and industry best practices.
• Demonstrated experience preparing and executing CQV documentation.

Responsibilities

• Plan, coordinate, and execute CQV activities for grey utility systems in accordance with project timelines and quality requirements.
• Prepare, review, and execute CQV protocols and reports: URS, FAT, SAT, DQ, IQ, OQ, and sometimes PQ, as relevant.
• Review and verify design and installation documentation (e.g. P&IDs, datasheets, equipment lists) for grey utilities.
• Interface with project engineering, automation, production, and quality teams throughout project lifecycle.
• Support utility system start-up, troubleshooting, issue resolution, and optimisation post-commissioning.
• Ensure strict compliance with pharmaceutical regulatory requirements (cGMP, FDA, EMA, ISPE, etc.).
• Coordinate with vendors and contractors for proper execution of commissioning and validation.
• Participate in risk assessments (e.g. HAZOP, FMEA) for relevant systems.
• Document and address deviations, CAPAs, and change controls as required.
• Maintain clear and organised records of all qualification activities and findings.
• Provide progress updates and participate in project meetings.
• Support training of operations and maintenance teams regarding qualified utilities.

Skills

CQV experience

Cross-functional collaboration

Documentation skills

Regulatory awareness

Education

Bachelor's degree in Engineering

Job description

HRM Search Partners seeks a CQV Engineer - Grey Utilities for a pharmaceutical environment in Ireland. You will lead commissioning, qualification and validation activities for grey utility systems, ensuring cGMP compliance and timely project deliverables.

Plan and execute CQV protocols (URS, FAT, SAT, DQ, IQ, OQ) and review design docs (P&IDs, datasheets). Coordinate with engineering, automation, production and quality teams to drive smooth start-up and post-commissioning support.