Act as the main point of contact for all CSV and Data Integrity topics related to laboratory equipment, manufacturing systems and IT systems
Define, implement and continuously improve CSV and Data Integrity strategies for projects (new equipment, upgrades, improvements) and routine activities
Ensure GMP-compliant validation lifecycle management of systems under your responsibility
Support investigations, deviations, and CAPAs related to computerized systems
Lead CSV-related inspection and audit preparation, acting as subject matter expert during regulatory inspections
Drive continuous improvement initiatives to strengthen system robustness and data integrity culture

Bachelor’s or Master’s degree in Engineering, Computer Science, Automation, Industrial Systems or related field
Minimum 5 years of experience in Computerized System Validation within the pharmaceutical or biotech industry
Strong knowledge of pharmaceutical requirements and guidelines (GMP – Annex 11, GAMP 5)
Good understanding of industrial automation systems (SCADA, PLC, recipe management systems)
Native or fluent French speaker with strong professional proficiency in English.

CSV Manager

About this role