Senior CQV Utilities Engineer - Onsite (Ireland) 6+ Months

Kpc International; Tralee; On-site; EUR 90,000 - 130,000; Full time

Job summary

KPC International is seeking a Senior CQV Utilities Engineer to support commissioning, qualification, and validation of critical utility systems in a pharmaceutical facility in Co. Kerry, Ireland. This hands-on role covers WFI, purified water, clean steam, HVAC, and distribution systems.

You will lead CQV protocol development, coordinate FAT/SAT/start-up testing, review design docs, and mentor junior engineers while ensuring cGMP compliance and timely delivery of validation deliverables.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Chemical, Bioprocess, or related). Masters preferred.
• 7 - 10+ years of experience in CQV or validation within pharmaceutical/biotech facilities, with at least 5 years in utilities-focused roles.
• In-depth knowledge of utility systems design, operation, and qualification.
• Strong understanding of cGMP, GAMP5, ISPE Baseline Guides, ASTM E2500, and regulatory guidelines.
• Proven track record of delivering CQV projects in large-scale manufacturing or facility start-ups.
• Excellent documentation, problem-solving, and project management skills.
• Strong leadership and mentoring abilities.

Responsibilities

• Development and execution of CQV protocols (IQ/OQ/PQ) for utility systems, ensuring compliance with cGMP, FDA, EMA, and ICH guidelines.
• Plan, coordinate, and execute commissioning activities including FATs, SATs, and start-up testing.
• Act as SME for clean and black utilities, including WFI, purified water, clean steam, HVAC, chilled water, compressed air, nitrogen, and waste systems.
• Review and approve design documentation (URS, P&IDs, specifications) to ensure qualification readiness.
• Manage deviations, change controls, and CAPAs associated with utility systems.
• Collaborate with design, construction, automation, and quality teams during project lifecycle.
• Provide technical guidance and mentoring to junior CQV engineers.
• Ensure validation deliverables are completed on time, within budget, and to the required quality standards.
• Support regulatory inspections and internal audits as the utility SME.
• Maintain compliance with data integrity principles and site documentation standards.

Skills

CQV experience

Validation

Leadership

Project management

Documentation

Problem-solving

Mentoring

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Tools

URS

P&IDs

IQ/OQ/PQ protocols

Job description

KPC International is seeking a Senior CQV Utilities Engineer to support commissioning, qualification, and validation of critical utility systems in a pharmaceutical facility in Co. Kerry, Ireland. This hands-on role covers WFI, purified water, clean steam, HVAC, and distribution systems.

You will lead CQV protocol development, coordinate FAT/SAT/start-up testing, review design docs, and mentor junior engineers while ensuring cGMP compliance and timely delivery of validation deliverables.