Sr. Computerized System Validation Specialist

As the CSV Specialist in Abbott Olst, you ensure compliant and reliable computerized systems within Manufacturing Automation. You act as the subject-matter expert for CSV, data integrity and GMP, guiding validations and governance. You will drive complex validation projects and translate evolving regulations into the organization. You join a cross-functional team to shape future CSV strategy for the Olst and Weesp sites, enabling compliant lifecycle management and continuous improvement.

• Prepare, review and coordinate validation documentation
• Handle deviations, exceptions and CAPAs
• Support audits and inspections
• Provide up-to-date information, reports and evaluations on Computer System Validation
• Collaborate with QA, Operations, Engineering and IT
• Ensure compliant lifecycle management of computerized systems
• Act as CSV project SME for automation-related projects

• Bachelor's or Master's level education in Process Engineering, Automation or Business IT
• 3-5 years of CSV experience in a GMP environment
• Demonstrated SME or lead experience in validation projects
• Knowledge of GAMP5, NIS2, GMP Annex 11, Data Integrity and CSA
• Strong stakeholder management and advisory skills
• Fluency in Dutch and English (spoken and written)

• Stakeholder management
• Advisory skills
• Coaching and mentoring
• CSV
• Data Integrity
• GAMP5