Facility & Utilities Qualification Engineer

Your Role

Joining Capgemini Engineering means stepping into a dynamic and highly regulated environment where your expertise directly contributes to the reliability and compliance of world-class pharmaceutical manufacturing facilities. As a Facility & Utilities Qualification Engineer, you will play a central role in ensuring that GMP facilities, HVAC systems, and critical utility infrastructure meet the highest regulatory and quality standards.

In this role you will play a key role in:

• Planning, coordinating, and executing qualification activities for facility and utility systems, including HVAC, cleanrooms, Purified Water (PW), Water for Injection (WFI), Clean Steam, Compressed Air, and Nitrogen, ensuring full compliance with GMP requirements and corporate standards
• Developing, reviewing, and managing the full suite of qualification lifecycle documentation — including Qualification Plans, Risk Assessments, IQ/OQ/PQ Protocols, Summary Reports, and Traceability Documentation — to support robust and audit-ready validation programmes
• Conducting HVAC qualification testing activities such as airflow visualisation studies, temperature and humidity mapping, pressure cascade verification, air change rate calculations, and HEPA filter integrity testing
• Supporting Commissioning, Qualification, and Validation (CQV) activities for Building Management Systems (BMS) and Environmental Monitoring Systems (EMS), as well as participating in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
• Collaborating cross-functionally with Engineering, Facilities, Quality Assurance, Manufacturing teams, and external contractors to drive qualification projects forward efficiently and on schedule
• Supporting deviations, investigations, change controls, and CAPA implementation, while contributing to internal and external regulatory inspections and audits in line with EU GMP Annex 1, Annex 15, and ISPE guidelines

Your Profile

• Holds a Bachelor's or Master's degree in Mechanical Engineering, Electromechanics, Facilities Engineering, or a related discipline
• Minimum 4 years of hands-on experience in pharmaceutical, biotechnology, or highly regulated manufacturing environments
• Demonstrates strong technical knowledge of HVAC systems, cleanroom technology, clean and critical utilities, Environmental Monitoring Systems, and Building Management Systems, alongside a solid understanding of GMP regulations, EU GMP Annex 1 & Annex 15, ISPE Baseline Guides, and ISO cleanroom standards
• Brings proven experience in CQV activities, temperature mapping, utility system performance testing, and deviation and change management processes
• Familiarity with electronic validation platforms such as Kneat, TrackWise, or Veeva is a strong advantage
• Communicates effectively with both technical and business stakeholders, demonstrating strong project coordination skills, attention to detail, and the ability to manage multiple priorities
• Fluent in English (mandatory) and Dutch (optional)
• Good mobility to Beerse

What You'll Love About Working Here

• Digital campuses and academy – Our engineering academy offers more than 60,000 hours of training, as well as our digital campus on GenAI, data or sustainability, supporting digital learning in the flow of work from awareness to expert certifications.
• FlexAbroad – Employees in 20+ countries can work abroad for up to 45 days in a 12-month period, giving you the flexibility to experience new environments while continuing your career journey.
• Mentoring programs – Capgemini empowers professionals at all career stages with mentoring programs spanning education to career re-entry, fostering professional growth and empowerment within our engineering community.