CSV Specialist

For our Engineering department (industrial automation) we are currently looking for a CSV Specialist. As a CSV Specialist you optimize and maintain the Computerized systems management and validation procedures and ensure optimal execution and continuous improvement of CSV processes per GMP (ISPE GAMP 5,21 CFR Part 11, Eudralex volume 4 Annex 11) standards. You lead or consult on CSV activities within IT/OT automation projects and changes to ensure adherence to GMP quality standards.

CSV Specialist

Key repsonsibilities:

Validation Strategy and Management:

Develop and maintain the validation strategy for computerized systems in line with GMP standards such as ISPE GAMP 5, 21 CFR Part 11, and Eudralex Volume 4 Annex 11. Ensure comprehensive management of validation activities to support regulatory compliance.

Execution of Validation Activities:

Execute validation processes, including plann...