Quality Assurance CSV Engineer | Life Sciences

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

Résumé du poste

Capgemini Engineering seeks a Quality Assurance CSV Engineer to join our Life Sciences team. You will support QA activities for computerized system validation projects and work under senior team members to ensure systems meet quality standards and regulatory requirements in the pharmaceutical industry.

You will assist with test protocols, documentation, and deviations while applying GxP regulations and 21 CFR Part 11. Beerse/Geel/Puurs/Ghent mobility is required.

Qualifications

• Master'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 apprenticeship.
• Understanding of quality management systems and computerized system validation principles.
• Good analytical and problem-solving skills with strong attention to detail.
• Ability to create clear and concise quality documentation following established templates.
• Fluent in English and Dutch.

Responsabilités

• Assist in executing test protocols and document results per QA procedures.
• Support review of validation documentation for completeness, accuracy, and regulatory compliance.
• Participate in system testing activities and document deviations or non-conformances.
• Learn and apply GxP regulations and 21 CFR Part 11 in CSV contexts.
• Contribute to quality metrics collection and reporting to track validation effectiveness and compliance.

Connaissances

Master's degree

CSV experience

Quality management

Analytical skills

Documentation

English

Dutch

Mobility

Formation

Master's degree in related field

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

As 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 procedures
• Supporting the review of validation documentation to ensure completeness, accuracy, and compliance with regulatory standards
• Participating in system testing activities and helping to identify and document deviations or non-conformances
• Learning and applying GxP regulations and 21 CFR Part 11 requirements in computerized system validation
• Contributing to quality metrics collection and reporting to track validation effectiveness and compliance

Your Profile

• Master'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 apprenticeship
• Understanding of quality management systems and computerized system validation principles
• Good analytical and problem-solving skills with strong attention to detail
• Ability to create clear and concise quality documentation following established templates
• Fluent in English and Dutch
• Good mobility to Beerse, Geel, Puurs or Ghent

What You Will Love About Working Here

• Empowering 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.