CSV Engineer — Global Pharma Validation & ISPE GAMP5

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

Avantages offerts par ce poste

Career acceleration programs

Continuous feedback

FlexAbroad

Résumé du poste

Capgemini Engineering in Belgium is seeking a Computer System Validation (CSV) Engineer to ensure that computerized systems in regulated environments meet compliance and function as intended. You will collaborate with cross-functional teams to develop and execute validation strategies aligned with industry regulations.

The role focuses on developing and executing validation protocols in pharmaceutical environments, applying ISPE GAMP5 principles, and analyzing and validating a wide range of

Qualifications

• Minimum 3 years experience in validation and qualification in the pharmaceutical industry (FDA, Eudralex, WHO) or equivalent environments (food, cosmetics).
• Strong knowledge of ISPE GAMP5 principles applied to quality, operational and project contexts.
• Excellent analytical skills to actively contribute to validation strategies and CSV activities.
• Fluency in both French and English (written and spoken).

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

GAMP5 knowledge

French & English fluency

CSV validation experience

Description du poste

Capgemini Engineering in Belgium is seeking a Computer System Validation (CSV) Engineer to ensure that computerized systems in regulated environments meet compliance and function as intended. You will collaborate with cross-functional teams to develop and execute validation strategies aligned with industry regulations.

The role focuses on developing and executing validation protocols in pharmaceutical environments, applying ISPE GAMP5 principles, and analyzing and validating a wide range of