QA Commissioning & Qualification | Life Sciences

Capgemini Engineering; Diegem; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Company car or mobility budget

Meal vouchers

Hospitalization & group insurance

Hybrid working options

Learning & development opportunities

Engineering community events

Résumé du poste

Capgemini Engineering Belgium is seeking a skilled QA professional to support qualification and lifecycle management of facilities and utilities. You will review URS, risk assessments, and PQ protocols, ensure compliance with regulations, and support audits.

Join a global engineering leader and contribute to cross-functional projects, driving continuous improvement and robust quality systems in a regulated environment, with opportunities for career growth in Beerse.

Qualifications

• Master's degree in Biomedical sciences or an equivalent field.
• Fluent in Dutch and English with strong communication skills.
• Experience in a regulated environment and QA oversight is preferred.
• Ability to work with cross-functional teams and challenge constructively.
• Mobility to the client site in Beerse.

Responsabilités

• Provide QA support with a primary focus on facilities and utilities (HVAC, water, gas).
• Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ).
• Review and approve procedures for qualification, calibration, maintenance, lifecycle management.
• Address deviations with appropriate corrective and preventive actions.
• Maintain knowledge of international regulations and industry practices.
• Support regulatory inspections, audits, and internal assessments.

Connaissances

QA oversight

Regulatory compliance

Change control

Audits & inspections

Cross-functional collaboration

Documentation & records

Dutch and English fluency

Formation

Master Biomedical sciences or similar

Description du poste

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 mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide 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 arethe 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.