Quality Assurance CSV Engineer | Life Sciences

Capgemini; Diegem; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Capgemini Engineering Belgium is seeking a Quality Assurance CSV Engineer to support validation projects in the life sciences domain. You will work under senior team members to ensure computerized systems meet quality standards and regulatory requirements.

Key tasks include executing test protocols, reviewing validation documentation, documenting deviations, applying GxP and 21 CFR Part 11 principles, and contributing to quality metrics. Mobility to Beerse, Geel, Puurs or Ghent is available.

Qualifications

• Master's degree in a related field required.
• Experience with computerized system validation (CSV) in a regulated environment.
• Strong understanding of quality management systems and CSV principles.
• Ability to create clear, concise quality documentation following templates.
• Fluent in English and Dutch.

Responsabilités

• Support quality assurance activities for CSV projects in life sciences.
• Assist in executing test protocols and document results per QA procedures.
• Review validation documentation for completeness and regulatory compliance.
• Support system testing and document deviations or non-conformances.
• Contribute to quality metrics collection and reporting.

Connaissances

CSV validation experience

Quality assurance

Regulatory compliance

Analytical thinking

Documentation skills

Formation

Master's degree in Biomedical Engineering / Pharmaceutical 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 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 RoleAs a Quality Assurance CSV Engineer, you will be part of our Life Sciences team, supporting quality assurance activities for computerized system validation projects. You will work under the guidance of senior team members to ensure systems meet quality standards and comply with regulatory requirements in the pharmaceutical industry.In this role you will play a key role in:Assisting in the execution of test protocols and documenting results according to established quality assurance proceduresSupporting the review of validation documentation to ensure completeness, accuracy, and compliance with regulatory standardsParticipating in system testing activities and helping to identify and document deviations or non-conformancesLearning and applying GxP regulations and 21 CFR Part 11 requirements in computerized system validationContributing to quality metrics collection and reporting to track validation effectiveness and complianceYour ProfileMaster's degree in a related field (e.g. Biomedical Engineering, Medical sciences, Pharmaceutical sciences or similar)Prior experience with computerized system validation (CSV) in a regulated environment is required through past experience, internship or apprenticeshipUnderstanding of quality management systems and computerized system validation principlesGood analytical and problem-solving skills with strong attention to detailAbility to create clear and concise quality documentation following established templatesFluent in English and DutchGood mobility to Beerse, Geel, Puurs or GhentWhat You Will Love About Working HereEmpowering environment - Autonomy and Goal setting are among the top scores with 8.4+ ratings in our monthly employee feedback Pulse.Inclusive leadership - Capgemini collaborates with global organizations to strengthen an equal opportunities framework, including promotion and pay, and to empower our leaders to develop inclusive behaviors and combat bias (97% of our VPs went through training on unconscious biases).FlexAbroad - Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.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.