CAI

Operational readiness consulting for pharma

CQV Lead Utilities

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

Full-timeNetherlandsNo salary listedIn-person

About the Job

Requirements

Experience in pharmaceutical or biopharmaceutical environments with team leadership responsibility.
Strong hands-on experience in commissioning utility systems.
Proven commissioning, qualification, and validation experience with clean and black utilities, including purified water, water for injection, clean steam, heating, ventilation, and air conditioning systems, process gases, and cooling towers.
Experience using Kneat; training will be provided if required.
Knowledge of Good Manufacturing Practice, ISPE Baseline Guides, and regulatory compliance requirements.
Ability to commit to a minimum 40-hour work week, with flexibility based on project needs.
Eligible to work in the European Union without the need for visa sponsorship, now or in the future.

Responsibilities

Lead a team of commissioning, qualification, and validation engineers, contractors, and specialists in commissioning and qualification activities.
Oversee commissioning, qualification, and validation activities for clean and black utility systems, including purified water, water for injection, clean steam, process gases, heating, ventilation, and air conditioning systems, and cooling towers.
Act as the commissioning, qualification, and validation subject matter expert for utilities throughout the project lifecycle.
Develop, execute, and approve commissioning and qualification documentation, including installation qualification and operational qualification, and performance qualification where applicable.
Lead and support commissioning activities, ensuring systems are installed, tested, and operate as designed.
Review and approve user requirements specifications, design specifications, risk assessments, and commissioning, qualification, and validation deliverables.
Ensure compliance with European Union Good Manufacturing Practice, Food and Drug Administration requirements, ISPE Baseline Guides, and internal quality standards.
Coordinate commissioning, qualification, and validation activities with Engineering, Quality, Automation, and Operations teams.
Monitor progress, resource allocation, and the quality of commissioning, qualification, and validation deliverables to ensure timelines are met.
Support deviations, change controls, and impact assessments related to utilities.
Represent the utilities team during regulatory inspections and audits.

CAI Overview

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

• We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:

• We act with integrity

• We serve each other

• We serve society

• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Job Title: CQV Lead Utilities

Location: Netherlands

Contract Type: Staff or Contract (12-month project)

Job Summary

We are seeking a CQV Lead – Utilities (Team Lead) to lead a team of engineers and specialists in the Commissioning, Qualification, and Validation (CQV) of critical utility systems within a GMP pharmaceutical environment. This role will be responsible for planning, coordinating, and overseeing CQV activities across clean and black utilities, ensuring successful delivery on time, on budget, and fully compliant with regulatory standards.

Key Responsibilities

•Lead and manage a team of CQV engineers, contractors, and specialists in all commissioning and qualification activities.

•Oversee CQV activities for clean and black utility systems (Purified Water (PW), WFI (Water for Injection), Clean Steam, Process Gases, HVAC systems, Cooling Towers).

•Act as the CQV Subject Matter Expert (SME) for utilities throughout the project lifecycle.

•Develop, execute, and approve commissioning and qualification documentation, including IQ/OQ (PQ where applicable).

•Lead and support commissioning activities, ensuring systems are installed, tested, and operate as designed.

•Review and approve URS, design specifications, risk assessments, and CQV deliverables.

•Ensure compliance with EU GMP, FDA, ISPE Baseline Guides, and internal quality standards.

•Coordinate CQV activities with Engineering, Quality, Automation, and Operations teams.

•Monitor progress, resource allocation, and quality of CQV deliverables, ensuring timelines are met.

•Support deviations, change controls, and impact assessments related to utilities.

•Represent the utilities team during regulatory inspections and audits.

Key Requirements

•Experience in pharmaceutical or biopharmaceutical environments with team leadership responsibility.

•Strong hands-on experience in Commissioning of utility systems (key requirement).

•Proven CQV experience with clean and black utilities, including PW, WFI, clean steam, HVAC, process gases, and cooling towers.

•Experience using Kneat (e-validation system) — training will be provided if required.

•Knowledge of GMP, ISPE Baseline Guides, and regulatory compliance requirements.

•Excellent leadership, communication, and stakeholder management skills.

•Ability to prioritize and manage multiple activities in a fast-paced project environment.

Other Requirements

• Must be able to commit to a minimum 40-hour work week, with flexibility based on project needs.

• This role is site based.

• Eligible to work in the EU without the need for visa sponsorship, now or in the future.

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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