CSV Engineer: Life Sciences Validation Specialist

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

Résumé du poste

Capgemini Engineering in Brussels seeks a CSV Engineer to validate computerised systems in Life Sciences. You will develop and execute CSV protocols in line with GAMP 5, 21 CFR Part 11 and EU Annex 11, ensuring compliance across the life cycle.

You will lead validation for MES, LIMS, ERP and process control systems, collaborating with IT, QA and operations to manage risks and deliver on time. Documentation, audits, and regulatory inspections are integral to the role.

Qualifications

• 2+ years in computer system validation within Life Sciences.
• Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity.
• Strong analytical and problem-solving skills with risk assessment.
• Degree in Computer Science, Engineering or Life Sciences and quality mindset.
• Proficiency in French and/or Dutch and English for Brussels environment.

Responsabilités

• Developing and executing CSV protocols per regulatory frameworks.
• Leading validation for MES, LIMS, ERP and process control systems.
• Collaborating with IT, QA and operations to define validation strategies.
• Preparing validation plans, specifications, traceability and reports.
• Supporting inspections and audits with audit-ready CSV documentation.

Connaissances

CSV validation

Regulatory knowledge

Analytical skills

Risk assessment

Multilingual communication

Cross-functional collaboration

Formation

Degree in Computer Science, Engineering or Life Sciences

Description du poste

Capgemini Engineering in Brussels seeks a CSV Engineer to validate computerised systems in Life Sciences. You will develop and execute CSV protocols in line with GAMP 5, 21 CFR Part 11 and EU Annex 11, ensuring compliance across the life cycle.

You will lead validation for MES, LIMS, ERP and process control systems, collaborating with IT, QA and operations to manage risks and deliver on time. Documentation, audits, and regulatory inspections are integral to the role.