Senior CQV Utilities Engineer

Company Overview

KPC International, operating since 2001, comprises a team of engineers and scientists dedicated to supporting pharmaceutical and biopharmaceutical projects globally. The organization specializes in the start-up of plant facilities spanning strategic planning, execution, and readiness for operations, assisting clients in delivering life-changing products to patients.

Role Overview

We are looking for an experienced Senior CQV (Commissioning, Qualification, and Validation) Utilities Engineer to join our pharmaceutical facility project based in County Kerry, Ireland. This role emphasizes the hands-on responsibility of ensuring that utility systems are aptly designed, installed, tested, and qualified to comply with regulatory standards and site quality procedures. The engineer will act as a subject matter expert for various utility systems including clean steam, Water for Injection (WFI), purified water, HVAC, compressed gases, and their distribution.

Key Responsibilities

• Develop and execute CQV protocols (Installation Qualification, Operational Qualification, Performance Qualification) to ensure adherence to cGMP, FDA, EMA, and ICH regulations.
• Lead planning, coordination, and execution of commissioning activities like Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and start-up testing.
• Serve as the subject matter expert in clean and utility systems including WFI, purified water, clean steam, HVAC, chilled water, compressed air, nitrogen, and waste management systems.
• Review and approve design documentation such as User Requirement Specifications (URS), Piping and Instrumentation Diagrams (P&IDs), and technical specifications to prepare for qualification.
• Manage deviations, change controls, and Corrective and Preventive Actions (CAPAs) associated with utilities.
• Collaborate effectively with design, construction, automation, and quality teams throughout the project lifecycle.
• Provide mentorship and technical guidance to junior engineers within the CQV team.
• Ensure that all validation deliverables meet deadlines, budget constraints, and quality standards.
• Support regulatory inspections and internal audits as the utilities expert.
• Maintain compliance with data integrity principles and uphold site documentation standards.

Qualifications and Experience

• Bachelor’s degree in Mechanical, Chemical, Bioprocess Engineering or a related discipline; Master’s degree preferred.
• A minimum of 7 years' experience in CQV or validation within pharmaceutical or biotech sectors, including at least 5 years focused on utilities engineering.
• Extensive understanding of utility systems design, operations, and qualification processes.
• Strong knowledge of current Good Manufacturing Practices (cGMP), GAMP5, ISPE Baseline Guides, ASTM E2500, and other relevant regulatory frameworks.
• Demonstrated successful delivery of CQV projects in large-scale manufacturing or facility start-ups.
• Proficiency in documentation, problem-solving, and project management.
• Proven leadership skills and abilities to mentor junior engineers.

Additional Information

This position is a contract role based onsite in Tralee, County Kerry, Ireland, with a minimum duration of six months. KPC International is committed to fostering an inclusive work environment that broadens your skills and experiences to positively impact healthcare. The company is an Equal Opportunity Employer.