Project CQV Engineer, Grey Utilities (12M, Limerick)

CareerWise Recruitment; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

CareerWise Recruitment is seeking a Project CQV Engineer for our multinational Life Sciences client in Limerick. The role focuses on commissioning, qualification and validation of grey utilities systems such as HVAC and non-process water.

Applicants should have 5+ years in CQV within regulated industries and familiarity with cGMP, FDA and EMA guidelines. The position requires on-site work in Limerick and collaboration with engineering, automation, production, and quality teams.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Minimum 5 years of CQV experience focusing on grey utilities in regulated industries.
• Deep knowledge of grey utilities including HVAC, non-process water, steam and compressed air.

Responsibilities

• Execute CQV activities for grey utilities systems in line with timelines and quality standards.
• Prepare, review and execute CQV protocols and reports (URS, FAT, SAT, DQ, IQ, OQ, PQ).
• Coordinate with engineering, automation, production and quality teams across the project lifecycle.
• Ensure compliance with pharmaceutical regulations (cGMP, FDA, EMA) and ISPE Baseline Guides.
• Support start-up, troubleshooting and optimization post-commissioning.

Skills

CQV experience

Grey utilities

GEP knowledge

cGMP compliance

FDA/EMA awareness

ISPE guidance

Project coordination

Risk assessment

Education

Bachelor’s degree in Engineering

Tools

CQV protocols

URs/DQ/IQ/OQ/PQ workflows

Job description

Project CQV ENGINEERS for Grey Utilities required by CareerWise for our multinational Life Sciences client in Limerick.

NOTE: No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.

Key Responsibilities

• Responsible for executing commissioning, qualification, and validation (CQV) activities for grey utilities systems (such as HVAC, non-process water, compressed air, steam, chilled water, etc.).


• Familiarity with GEP, cGMP, FDA, EMA, ISPE Baseline Guides and industry best practices.


• Plan, coordinate, and execute CQV activities for all 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 optimization 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 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.

Qualifications & Experience

• Bachelor’s degree (or higher) in Engineering (Mechanical, Chemical, Electrical), or relevant technical field.


• Minimum 5 years’ experience 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.


• Proven track record collaborating with multidisciplinary teams.