CSV Specialist

At Abbott Olst, we work every day on life-saving nutritional and pharmaceutical products. Within Manufacturing Automation, we are looking for a CSV Specialist who ensures reliable and compliant computerized systems. Location: Olst, The Netherlands. This is an onsite position that requires you to be onsite a minimum of 4 days a week. About the Department Manufacturing Automation consists of Application Managers, Automation Engineers and MES Designers and supports production, laboratories, facilities and utilities. The department forms the bridge between technology, compliance and the production departments. The role You are the SME for CSV, Data Integrity and GMP compliance; You lead complex validation and implementation projects; You develop CSV standards, governance and procedures; You translate new regulations such as NIS2, Annex 11 and CSA into the organization; You coach colleagues and advise management and project owners; You actively contribute to the future CSV strategy for the Olst and Weesp sites (OneNL). Your Responsibilities Prepare, review and effectively coordinate validation documentation Handle deviations, exceptions and CAPAs Support audits and inspections Ensure continuous availability of up-to-date information, reports and evaluations regarding Computer System Validation Collaborate with QA, Operations, Engineering and IT Ensure compliant lifecycle management of computerized systems Act as the CSV project SME for projects involving automation aspects., You will have a visible role within a modern pharmaceutical environment where digitalization, compliance and continuous improvement are central. You will work with experts from various disciplines and have ample opportunities for development and impact.

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