Sr. Computerized System Validation Specialist

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

Job summary

Abbott Olst is seeking a CSV Specialist to ensure reliable and compliant computerized systems within Manufacturing Automation. You will be the SME for CSV, data integrity and GMP compliance, and you will lead complex validation and implementation projects.

Onsite in Olst, The Netherlands, you will translate regulations such as NIS2, Annex 11 and CSA into the organization, coach colleagues and help shape the CSV strategy for the Olst and Weesp sites (OneNL).

Qualifications

• Must have 3–5 years of CSV experience in GMP environments.
• Strong knowledge of data integrity and regulatory requirements.
• Experience as SME or lead in validation projects with cross-functional teams.

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.
• Ensure compliant lifecycle management of computerized systems.
• Act as the CSV project SME for automation-related projects.

Skills

Data integrity

GMP compliance

Stakeholder management

Advisory abilities

Education

Bachelor's or Master’s in Process Engineering, Automation or Business IT

Tools

GAMP5

NIS2 compliance

CSA standards

Job description

CSV SpecialistAt 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.