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