Sr. Computerized System Validation Specialist

• 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

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.

• 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).

• 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.

Location: Olst, The Netherlands. This is an onsite position that requires you to be onsite a minimum of 4 days a week.

Standard

Not specified

Operations Quality

EPD Established Pharma

Netherlands > Olst : OAA/OAB

Not Applicable

Not Applicable