CQV Utilities Lead

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.

Position Overview

The Utilities Lead is responsible for the design, operation, and maintenance of critical utility systems—including water, steam, process gases, and HVAC—within a pharmaceutical manufacturing environment. This role ensures compliance with GMP and global regulatory standards while driving system reliability, safety, and efficiency. The Utilities Lead will provide technical expertise, manage commissioning and qualification (C&Q) activities, and collaborate with cross-functional teams to support ongoing manufacturing operations.

Key Responsibilities

Project Leadership & C&Q

• Lead and manage commissioning and qualification (C&Q) activities for clean utilities ensuring compliance with GMP and regulatory requirements.
• Oversee project execution, risk assessments, and resolution of technical issues.

System Design & Operation

• Direct the design, installation, operation, and maintenance of utility systems (WFI, clean steam, HVAC, process gases).
• Ensure optimal performance, reliability, and safety of systems supporting manufacturing processes.

Regulatory Compliance

• Maintain compliance with global regulatory standards and internal quality requirements.
• Ensure accurate documentation and validation in line with GMP standards.

Documentation & Reporting

• Develop and manage C&Q protocols, risk assessments, and project documentation.
• Provide regular progress updates and escalate issues proactively.

Cross-Functional Collaboration

• Partner with Engineering, Operations, Quality, and external vendors to align project objectives and resolve discrepancies.

Technical Expertise

• Serve as a Subject Matter Expert (SME) for utilities systems, providing troubleshooting and technical guidance.

Process & System Improvement

• Drive continuous improvement initiatives, including energy efficiency and cost-saving strategies.
• Analyse performance data to benchmark and optimize utilities usage.

Vendor Management

• Build and manage relationships with equipment suppliers and service providers during commissioning and maintenance activities.

Qualifications & Skills

Education

• Bachelor's or Master's degree in Mechanical Engineering, Process Engineering, or a related discipline.

Experience

• 5–10+ years of relevant engineering experience, ideally in the pharmaceutical or biotechnology industry.
• Proven background in utilities management and GMP-regulated environments.
• Fluency in English. German is a distinct advantage.

Technical Knowledge

• Strong expertise in clean utilities (WFI, clean steam, process gases), HVAC systems, and GMP requirements.

Soft Skills

• Demonstrated leadership and project management abilities.
• Strong problem-solving and analytical skills.
• Excellent verbal and written communication, with attention to detail.

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.