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Employer job description
From CAI's posting. “We” and “our” refer to the employer.
At CAI, we help our clients deliver critical life sciences facilities safely, efficiently and compliantly. We provide technical expertise across commissioning, qualification, validation and operational readiness programmes.
We are seeking an experienced Lead Commissioning & Qualification Engineer - Utilities to support a major European pharmaceutical manufacturing expansion project.
Position Summary
The Lead C&Q Engineer - Utilities will provide technical leadership for commissioning and qualification activities relating to critical utility systems supporting GMP manufacturing operations.
This role will focus on utility generation and distribution systems, leading teams through design review, commissioning planning, field execution, qualification and final handover.
Responsibilities
- Lead CQV activities for utility systems including purified water, WFI, clean steam, process gases, clean compressed air and supporting utility infrastructure.
- Review design packages, engineering deliverables and vendor documentation.
- Develop and approve qualification strategies and CQV lifecycle documentation.
- Coordinate FATs, SATs, commissioning and qualification activities.
- Lead construction walkdowns, turnover inspections and punch list closure programmes.
- Support startup, operational verification and GMP readiness activities.
- Manage utility system schedules and coordinate execution across multiple disciplines.
- Interface with engineering, construction, automation, quality, operations and maintenance teams.
- Provide technical leadership to CQV engineers and contractors.
- Ensure systems are delivered in accordance with project quality, safety and compliance requirements.
Requirements
- Degree in Engineering or related field.
- 10+ years' experience delivering CQV programmes for pharmaceutical utility systems.
- Strong knowledge of purified water, WFI, clean steam, compressed gases and utility distribution systems.
- Experience leading teams on large-scale GMP capital projects.
- Knowledge of ASTM E2500, ISPE guidance and risk-based CQV methodologies.
- Experience with Kneat and electronic lifecycle documentation systems is advantageous.
- Excellent planning, coordination and leadership capabilities.
- Willingness to work on-site within Europe as project demands require.
- European Pharmaceutical Projects | Initial Assignment in Germany
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