Senior CSV Lead: Data Integrity & GMP Compliance

Abbott; 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

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.