IT Validation Engineer (CSV/CSA) — GxP Compliance

Prothya Biosolutions; Amsterdam; On-site; EUR 52,000 - 75,000; Full time

Benefits offered by this job

8.33? holiday allowance

13th month

30 holiday days

Training budget

Travel expense reimbursement

Pension plan

Job summary

Prothya Biosolutions in the Netherlands seeks a Validation Engineer IT to lead and execute CSV/CSA activities across GxP systems and IT/OT environments. You will ensure compliance with EU GMP Annex 11 and FDA 21 CFR Part 11, and deliver inspection-ready documentation.

Join a cross-functional team spanning Quality, IT, Engineering and Manufacturing to advance digital transformation projects while maintaining rigorous validation standards and data integrity.

Qualifications

• Bachelor's degree in a relevant field.
• Certifications in Validation, GAMP, CSV/CSA are advantageous.
• >5 years in Computer System Validation, Compliance, Quality Systems, or Validation Engineering.

Responsibilities

• Execute CSV/CSA activities for GxP-relevant systems.
• Ensure compliance with GxP, Data Integrity, Annex 11 and Part 11.
• Prepare validation deliverables (IQ/OQ/PQ, test scripts, SARs).
• Support audits, inspections, and change control activities.
• Collaborate with Quality, IT, Engineering, Manufacturing and vendors.

Skills

CSV/CSA expertise

GxP compliance

Validation documentation

Risk assessment

Audit readiness

Technical writing

Education

Bachelor's degree in Engineering, Life Sciences, IT or related

Tools

ERP

MES

LIMS

QMS

Workflow platforms

Job description

Prothya Biosolutions in the Netherlands seeks a Validation Engineer IT to lead and execute CSV/CSA activities across GxP systems and IT/OT environments. You will ensure compliance with EU GMP Annex 11 and FDA 21 CFR Part 11, and deliver inspection-ready documentation.

Join a cross-functional team spanning Quality, IT, Engineering and Manufacturing to advance digital transformation projects while maintaining rigorous validation standards and data integrity.