CAI

Operational readiness consulting for pharma

Lead Commissioning and Qualification Engineer - Utilities - Utilities

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeNo salary listed

About the Job

Requirements

A degree in Engineering or a related field is required.
At least 10 years of experience delivering commissioning, qualification and validation programs for pharmaceutical utility systems is required.
Strong knowledge of purified water, water for injection, clean steam, compressed gases and utility distribution systems is required.
Experience leading teams on large-scale good manufacturing practice capital projects is required.
Knowledge of ASTM E2500, ISPE guidance and risk-based commissioning, qualification and validation methodologies is required.
Excellent planning, coordination and leadership capabilities are required.
Willingness to work on-site within Europe as project demands require is required.

Responsibilities

Lead commissioning, qualification and validation activities for utility systems, including purified water, water for injection, 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 commissioning, qualification and validation lifecycle documentation.
Coordinate factory acceptance tests, site acceptance tests, commissioning and qualification activities.
Lead construction walkdowns, turnover inspections and punch list closure programs.
Support startup, operational verification and good manufacturing practice 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 commissioning, qualification and validation engineers and contractors.
Ensure systems are delivered in accordance with project quality, safety and compliance requirements.

Desired Qualifications

Experience with Kneat and electronic lifecycle documentation systems is advantageous.

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

About the Company

CAI

Operational readiness consulting for pharma

CAI Technical Consulting Malaysia SDN (brand cagents.com) provides operational readiness consulting for pharmaceutical, biotech, and healthcare firms. It helps clients prepare for full-scale production through quick operational readiness assessments, gap-tailored plans, and hands-on implementation support in areas like project planning, production operations, asset management, reliability, and sustainability, plus Digital Pathology Validation for Leica Biosystems to meet regulatory standards. The firm differentiates itself by combining rapid assessments with practical, cost-effective strategies, ongoing industry collaboration, and global delivery that informs tailored solutions. Its goal is to help clients accelerate their path to compliant, scalable operations and successful production scale-up.

Company size: 1,001-5,000
Company stage: Pre-seed
Total funding: $3.4M
Headquarters: Indianapolis, IN
Founded: 1996

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