CQV Lead Utilities
About the job
- 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.
- 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.
About the company
CAI Technical Consulting Malaysia SDN (cagents.com) delivers operational readiness consulting for pharmaceutical, biotechnology, and healthcare clients to prepare for full-scale production. It works by conducting operational readiness assessments and then providing tailored implementation plans that cover project planning, production operations, asset management, reliability, and sustainability, plus specialized services like Digital Pathology Validation for Leica Biosystems. The firm differentiates itself through active industry collaboration, ongoing professional development, and a global, hands-on approach that pairs quick assessments with practical, cost-effective solutions. Its goal is to help clients achieve operational excellence and successful scale-up by delivering ready-to-deploy strategies and compliant processes.
Company Size
1,001-5,000
Company Stage
Pre-seed
Total Funding
$3.4M
Headquarters
Indianapolis, Indiana
Founded
1996
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Simplify's Take
What believers are saying
- CAI closed its JLL recapitalization on July 1, 2026, funding acquisitions and technology.
- CAI expanded Australia hiring in Melbourne and Brisbane during 2026.
- CAI grew past 850 employees worldwide, signaling sustained demand for CQV services.
What critics are saying
- JLL Partners owns CAI after July 1, 2026 recapitalization, forcing exit pressure.
- CAI depends on regulated-industry capital spending; project delays hit utilization fast.
- Integrated rivals like Jacobs and Thermo Fisher target the same validation and readiness work.
What makes CAI unique
- CAI specializes in CQV for FDA-regulated and mission-critical facilities since 1996.
- CAI spans life sciences, data centers, and process manufacturing across North America, Europe, Australia, Asia.
- CAI pairs consulting with turnkey partnerships like Fedegari for sterilization implementation.
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Benefits
100% Employee Owned
24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
Professional Development (Approximately $5,000 paid career-related, continuing education)
ESOP/401k – 15% Company Contribution
Company Paid Long-Term Disability
Company Paid Life Insurance
Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
Other Benefits Depending on Country
Growth & Insights and Company News
6 month growth
4%1 year growth
4%2 year growth
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CAI, a professional services firm specialising in operational readiness for life sciences and mission-critical environments, has agreed to a partnership with New York-based private equity firm JLL Partners to support its next growth phase. The investment will enable CAI to expand its global presence, invest in advanced technologies and enhance its service offerings. The company, which has operated for over 30 years, employs more than 700 professionals across North America, Europe, Australia and Asia. JLL Partners managing director Vikas Mouli cited CAI's reputation for launching cutting-edge facilities with precision and reliability. The transaction has signed definitive documentation but has not yet closed, pending regulatory approvals. CAI specialises in commissioning, qualification and validation services for highly regulated environments, helping organisations deploy complex facilities, systems and technologies.
/PRNewswire/ -- CAI, a professional services firm dedicated to accelerating operational readiness and excellence in life sciences and mission-critical...
INDIANAPOLIS--(BUSINESS WIRE)--CAI, a global company that provides technical, operational consulting, and project management services, today announced its strategic partnership with Fedegari Group, a manufacturer and service provider of high-performance sterilization systems. This partnership will elevate steam sterilization capabilities for companies spanning the life sciences and biotech industries. The goal of the partnership is to improve the application of steam sterilization science and minimize sterilization process implementation time, in order to reduce lifecycle costs, lower cost of goods, as well as streamline manufacturing processes. According to the terms of the partnership, Fedegari and CAI will integrate their offerings to provide a seamless experience from procurement to operation. In addition, the partners will cooperate on developing and validating state-of-the-art sterilization technology, driving science-based sterilization process and protecting both sensitive products and process equipment. "Fedegari is a world leader in providing aseptic manufacturing solutions, without operator intervention to produce advanced sterile products
Xtalks Life Science Webinars. . His wide-ranging expertise and experience will be integral to the discussion, particularly regarding the development and implementation of successful training programs