Senior CQV Utilities Engineer

About the Role

KPC International has been delivering engineering and scientific support since 2001, helping clients achieve successful projects across the pharmaceutical and biopharmaceutical sectors worldwide. The company focuses on plant and facility start-up work, covering everything from strategy and planning through execution and operational readiness, with a strong emphasis on supporting the delivery of therapies that improve patient lives.

They are now looking for a Senior CQV Utilities Engineer in Kerry, Ireland, to support the commissioning, qualification, and validation of essential utility systems in a pharmaceutical manufacturing environment. This is a practical, site-based position where the engineer will help confirm that utilities are properly designed, installed, tested, and qualified in line with regulatory expectations, industry standards, and site quality procedures. The role will also act as the technical lead for utility systems such as clean steam, WFI, purified water, HVAC, compressed gases, and related distribution networks.

This assignment is an onsite contract expected to run for 6 months or more.

Key Responsibilities

• Create, review, and carry out CQV documentation and protocols for utility systems, including IQ, OQ, and PQ activities, while maintaining alignment with cGMP, FDA, EMA, and ICH requirements.
• Organize and perform commissioning work such as FATs, SATs, and start-up testing.
• Serve as the technical authority for clean and black utilities, including WFI, purified water, clean steam, HVAC, chilled water, compressed air, nitrogen, and waste systems.
• Evaluate and sign off on design documents such as URS, P&IDs, and system specifications to confirm readiness for qualification.
• Oversee deviations, change controls, and CAPAs related to utility systems.
• Work closely with design, construction, automation, and quality teams throughout the project lifecycle.
• Guide and support junior CQV engineers through coaching and technical mentoring.
• Ensure validation deliverables are completed on schedule, within budget, and to the required quality level.
• Support audits and regulatory inspections by representing the utilities function as the subject matter expert.
• Follow data integrity requirements and maintain site documentation standards.

Requirements

• A bachelor’s degree in engineering such as Mechanical, Chemical, Bioprocess, or a similar discipline is required; a master’s degree is preferred.
• Between 7 and 10+ years of experience in CQV or validation work within pharmaceutical or biotech facilities, with at least 5 years focused on utilities.
• Strong working knowledge of utility system design, operation, and qualification activities.
• Good understanding of cGMP, GAMP5, ISPE Baseline Guides, ASTM E2500, and related regulatory frameworks.
• Demonstrated success in delivering CQV projects for large-scale manufacturing sites or facility start-up programs.
• Excellent documentation, troubleshooting, and project coordination capabilities.
• Proven leadership skills, including the ability to mentor and support others.

Additional Information

KPC International describes itself as an inclusive employer and an Equal Opportunity Employer. The organization values the chance to broaden experience, perspective, and skills while contributing to meaningful work that can positively affect others.

This role is based in Tralee, County Kerry, Ireland.