CSV QA Engineer – Life Sciences, Global Mobility

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

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.