Senior CQV Utilities Engineer

KPC International - Excellence from Concept to Completion

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.

Role Overview

The
Senior CQV Utilities Engineer
will lead commissioning, qualification, and validation (CQV) activities for critical utility systems in support of pharmaceutical/biotechnology facility startup and ongoing operations. This role will ensure utilities are designed, installed, tested, and qualified in compliance with regulatory requirements, industry standards, and site quality procedures. The engineer will serve as a subject matter expert (SME) for utilities such as clean steam, WFI, purified water, HVAC, compressed gases, and related distribution systems.

Key Responsibilities

• Lead the 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 but not limited to: 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.

Qualifications & Experience

• Bachelor's degree in engineering (Mechanical, Chemical, Bioprocess, or related field). Masters preferred.
• 8+ 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.

Key Competencies

• Technical expertise in critical utilities.
• Ability to work cross-functionally in a fast-paced, project-driven environment.
• Strong analytical and troubleshooting skills.
• Effective communication and stakeholder management.
• Detail-oriented with strong organizational skills.
• Fluency in English. German a distinct advantage.

KPC International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.
KPC – International is an Equal Opportunity Employer.