C

CAI

Operational readiness consulting for pharma

Senior CQV Utilities Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNetherlandsNo salary listedIn-person

About the Job

Requirements

  • Five to eight years of relevant experience in pharmaceutical utilities.
  • Proven commissioning, qualification, and validation experience with clean and black utilities, including purified water, water for injection, clean steam, heating, ventilation, and air conditioning, process gases, and cooling towers.
  • Knowledge of Good Manufacturing Practices, regulatory requirements, and validation protocols.
  • Ability to work independently in a project-driven environment.
  • Ability to commit to a minimum 40-hour work week, with flexibility based on project needs.
  • Must be eligible to work in the European Union without visa sponsorship, now or in the future.
  • The role is site-based.

Responsibilities

  • Design, operate, and maintain utility systems, including water for injection, purified water, cleaning steam, compressed gases, and cooling towers.
  • Perform system validation and support installation qualification, operational qualification, and performance qualification activities using an electronic validation system.
  • Ensure compliance with Good Manufacturing Practices, regulatory standards, and internal quality policies.
  • Monitor system performance, troubleshoot issues, and implement improvements.
  • Collaborate with production, quality, and engineering teams to ensure seamless operations.
  • Support audits and regulatory inspections.

Desired Qualifications

  • Familiarity with Kneat, an electronic validation system; training will be provided.

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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