Computer System Validation Lead (CSV & Data Integrity)

About the role

This position is based in Geel, Belgium and leads the Computer System Validation (CSV) and Data Integrity (DI) squad for a global pharmaceutical site. The role requires strong technical expertise and leadership to drive compliance across manufacturing systems while mentoring local process owners.

Key responsibilities

• Lead CSV and DI initiatives across manufacturing control systems.
• Ensure compliance with FDA, EMA and other regulatory standards.
• Mentor and support local process owners on validation and data integrity practices.
• Coordinate validation activities, risk assessments and change management projects.
• Collaborate with engineering and quality teams to implement and maintain system controls.
• Provide technical guidance on alarm management and system configuration.

Required profile

• 8‑10 years of experience in computer system validation and data integrity within a pharmaceutical manufacturing environment.
• Strong knowledge of FDA and EMA regulatory requirements and risk‑based validation approaches.
• Proven project management, change management and team leadership skills.
• Fluent in English; Dutch is a plus.

Required skills

• DeltaV
• PI System
• PCS7
• PLC
• SCADA
• Alarm management