CSV Engineer – Pharma Validation & GAMP5 Expert

Capgemini Engineering; Diegem; Sur place; EUR 50 000 - 61 000; Plein temps

Résumé du poste

Capgemini Engineering in Belgium seeks a Computer System Validation (CSV) Engineer to ensure computerized systems in regulated environments comply with standards and perform as intended. You will collaborate with cross-functional teams to develop and execute validation strategies aligned with industry regulations.

The role emphasizes developing and executing validation protocols in pharmaceutical environments, applying ISPE GAMP5 principles across quality, operations and projects, and validating

Qualifications

• 3+ years of validation and qualification experience in the pharmaceutical industry (FDA, Eudralex, WHO) or equivalent environments (food, cosmetics).
• Strong knowledge of ISPE GAMP5 principles and their application to quality, operations and projects.
• Excellent analytical skills to contribute to validation strategies and CSV activities.

Responsabilités

• Developing and executing validation protocols in pharmaceutical environments.
• Implementing ISPE GAMP5 principles within quality, operational, and project contexts.
• Analyzing and validating a wide range of technical systems, including automated systems in regulated environments.

Connaissances

Validation & qualification experience

ISPE GAMP5 knowledge

Analytical skills

Bilingual French & English

Description du poste

Capgemini Engineering in Belgium seeks a Computer System Validation (CSV) Engineer to ensure computerized systems in regulated environments comply with standards and perform as intended. You will collaborate with cross-functional teams to develop and execute validation strategies aligned with industry regulations.

The role emphasizes developing and executing validation protocols in pharmaceutical environments, applying ISPE GAMP5 principles across quality, operations and projects, and validating