QA Commissioning & Qualification | Life Sciences

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Your Role

• Provide QA support with a primary focus on facilities and utilities (e.g. HVAC, water systems,

gas systems).

• Participate in change projects throughout the entire system lifecycle. Review and approve

qualification deliverables including User Requirements Specifications (URS), risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, qualification reports, ... to ensure compliance with applicable regulations, industry guidelines, and J&J policies and standards.

• Review and approve procedures related to qualification, calibration, maintenance and lifecycle

management of systems.

• Ensure that deviations related to systems (qualification, maintenance, calibration and/or use)

with potential impact on quality and/or compliance are appropriately assessed, thoroughly investigated and effectively addressed through adequate corrective and preventive actions.

• Maintain a current understanding of applicable international regulations, guidelines and

industry practices related to system qualification and apply this knowledge to continuously improve qualification processes.

• Support regulatory inspections, customer audits, and internal compliance assessments by

ensuring audit readiness and providing subject matter expertise on qualification-related topics.

• Collaborate closely with cross-functional stakeholders involved in qualification and lifecycle

management activities to ensure project timelines are achieved and organizational objectives are met.

Your Profile

• Master Biomedical sciences or similar.

• Fluent in Dutch and English.

• Good mobility to the client in Beerse.

• Two to ten years experience as a QA professional in a regulated environment.

• Experience in QA oversight of facilities and utilities is preferred, although candidates with a strong interest in

this area are also encouraged to apply.

• Strong quality and compliance mindset.

• Strong communication skills.

• The ability to challenge constructively while maintaining a positive and productive relation with

the stakeholders.

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.

Engineering Horizons A global conference crafted exclusively for Capgemini Engineering colleagues, where excellence takes centre stage. Immerse yourself in opportunities to showcase your talents and connect with the brightest minds in engineering across the planet.

Life at Capgemini Engineering in Belgium

At Capgemini Engineering Belgium, we offer a stimulating and inclusive work environment where your growth and well-being are a priority. You'll benefit from:

• A competitive salary package with company car or mobility budget, meal vouchers, hospitalization and group insurance

• Flexible working arrangements, including hybrid working options

• A wide range of learning and development opportunities through our internal academies and external training programmes

• Access to our vibrant local engineering community, with regular knowledge-sharing events, tech talks, and team activities

• A diverse and welcoming culture where everyone is encouraged to bring their whole self to work

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.