CSV Engineer — Life Sciences Validation Lead

Capgemini Engineering; Diegem; Sur place; EUR 52 000 - 70 000; Plein temps

Résumé du poste

Capgemini Engineering in Belgium is seeking a CSV Engineer to validate computerised systems in the Life Sciences sector. You will develop and execute CSV protocols, lead validation activities across MES, LIMS, ERP, and process control systems, and collaborate with IT, QA, and operations to ensure regulatory compliance.

The role emphasizes risk-based validation, documentation, and audit readiness, with fluency in French and/or Dutch and English to operate in Brussels' multilingual setting.

Qualifications

• A minimum of 2 years of experience in computer system validation within the Life Sciences industry, including pharmaceuticals, biotechnology, or medical devices.
• Strong knowledge of regulatory guidelines including GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Excellent analytical and problem-solving skills with a structured risk assessment and multi-project management approach.
• A degree in Computer Science, Engineering, Life Sciences, or related field with attention to quality and compliance.
• Proficiency in French and/or Dutch, plus English for Brussels’ multilingual environment.

Responsabilités

• Developing and executing CSV protocols in line with GAMP 5 and applicable regulations.
• Leading validation activities for MES, LIMS, ERP, and process control systems from requirements to final reports.
• Collaborating with IT, QA, and operations to define validation strategies and manage risks.
• Preparing validation plans, specifications, traceability matrices, tests, and summary reports.
• Supporting regulatory inspections and audits with audit-ready CSV documentation.

Connaissances

CSV validation

Regulatory know-how

Documentation

Risk assessment

Analytical skills

Languages

Formation

Relevant degree in Computer Science/Engineering/Life Sciences

Description du poste

Capgemini Engineering in Belgium is seeking a CSV Engineer to validate computerised systems in the Life Sciences sector. You will develop and execute CSV protocols, lead validation activities across MES, LIMS, ERP, and process control systems, and collaborate with IT, QA, and operations to ensure regulatory compliance.

The role emphasizes risk-based validation, documentation, and audit readiness, with fluency in French and/or Dutch and English to operate in Brussels' multilingual setting.