CQV Utilities

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.