CQV Project Engineer: Grey Utilities (Life Sciences)

CareerWise Recruitment; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

CareerWise Recruitment seeks Project Engineers for HVAC and grey utilities CQV activities in Limerick for a multinational Life Sciences client. You will execute commissioning, qualification, and validation for HVAC, water systems, steam and related utilities in a strictly regulated environment.

The role requires a bachelor’s degree in engineering and at least 5 years in CQV for grey utilities, with strong knowledge of cGMP, FDA/EMA guidance and ISPE baselines.

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 5 years’ CQV experience with grey utilities in pharmaceutical or related regulated industry.
• In-depth 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.

Responsibilities

• Plan, coordinate, and execute CQV activities for grey utility systems according to project 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) for grey utilities.
• Interface with project engineering, automation, production, and quality teams throughout the 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 (HBZOP? 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

cGMP familiarity

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Job description

CareerWise Recruitment seeks Project Engineers for HVAC and grey utilities CQV activities in Limerick for a multinational Life Sciences client. You will execute commissioning, qualification, and validation for HVAC, water systems, steam and related utilities in a strictly regulated environment.

The role requires a bachelor’s degree in engineering and at least 5 years in CQV for grey utilities, with strong knowledge of cGMP, FDA/EMA guidance and ISPE baselines.