CSV Specialist: Data Integrity & GMP Compliance Lead

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

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).