QA CSV Engineer – Life Sciences (GxP/21 CFR Part 11)

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

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.