Senior CQV Engineer – Grey Utilities (Pharma)

CareerWise Recruitment; Limerick; On-site; EUR 70,000 - 90,000; Full time

Job summary

CareerWise Recruitment is seeking CQV Engineers for a multinational Life Sciences client in Limerick. You will execute commissioning, qualification and validation activities for grey utilities systems such as HVAC, non-process water, compressed air, steam and chilled water.

The role requires a Bachelor's degree in Engineering and at least 5 years of CQV experience in regulated industry, with familiarity with cGMP, FDA, EMA and ISPE Baseline Guides.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years in CQV roles focusing on grey utilities in regulated industry.
• Knowledge of grey utility systems: HVAC, non-process water, compressed air, steam, chilled water, etc.
• Familiarity with GEP, cGMP, FDA, EMA, ISPE Baseline Guides and industry best practices.
• Experience preparing and executing CQV documentation.

Responsibilities

• Plan, coordinate, and execute CQV activities for grey utility systems per timelines and quality requirements.
• Prepare, review, and execute CQV protocols and reports: URS, FAT, SAT, DQ, IQ, OQ, and sometimes PQ.
• Review and verify design and installation documentation (P&IDs, datasheets, equipment lists).
• Interface with project engineering, automation, production, and quality teams throughout project lifecycle.
• Support utility system start-up, troubleshooting, issue resolution, and optimization post-commissioning.
• Ensure strict compliance with pharmaceutical regulatory requirements (cGMP, FDA, EMA, ISPE).
• Coordinate with vendors and contractors for proper execution of commissioning and validation.
• Participate in risk assessments (HAZOP, FMEA) for relevant systems.
• Document and address deviations, CAPAs, and change controls as required.
• Maintain clear and organized 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

Regulatory knowledge

Documentation

Project coordination

Stakeholder communication

Education

Bachelor's degree in Engineering

Tools

Qualification protocols

Job description

CareerWise Recruitment is seeking CQV Engineers for a multinational Life Sciences client in Limerick. You will execute commissioning, qualification and validation activities for grey utilities systems such as HVAC, non-process water, compressed air, steam and chilled water.

The role requires a Bachelor's degree in Engineering and at least 5 years of CQV experience in regulated industry, with familiarity with cGMP, FDA, EMA and ISPE Baseline Guides.