Sr. Computerized System Validation Specialist

Abbott Laboratories; Olst-Wijhe; On-site; EUR 70,000 - 100,000; Full time

Job summary

Abbott Laboratories in Olst, The Netherlands, is seeking a Senior CSV Specialist to ensure reliable validated computerized systems. This onsite role requires collaboration with QA, Operations, IT and Engineering to maintain GMP compliance and data integrity.

You will lead validation projects, develop CSV standards, translate regulations such as NIS2 and GMP Annex 11 into practice, and mentor colleagues on regulatory requirements. Fluency in Dutch and English is essential.

Qualifications

• Experience in CSV within GMP environments.
• SME or lead role in validation projects.
• Knowledge of GAMP5, NIS2, GMP Annex 11, Data Integrity and CSA.
• Fluency in Dutch and English, written and spoken.
• Strong stakeholder advisory and communication skills.

Responsibilities

• Prepare, review and coordinate validation documentation.
• Handle deviations, exceptions and CAPAs.
• Support audits and inspections.
• Ensure up‑to‑date information, reports and evaluations on Computer System Validation.
• Collaborate with QA, Operations, Engineering and IT.
• Act as the CSV project SME for automation projects.

Skills

CSV expertise

Data Integrity

GMP compliance

Stakeholder mgmt

Dutch language

English language

Education

BSc/MSc in Process Eng / Automation / Business IT

Job description

Senior 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.

What Do You Bring?

• 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

Why Abbott?

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.