Computer System Validation (CSV) Lead

Computer System Validation (CSV) Lead & Specialists

QbD Group supports companies in Pharma, ATMP and Medical Devices/IVD with expert knowledge and tailored software solutions. We are looking for CSV Leads and CSV Specialists to support GxP computerized systems validation projects.

💡 What’s in it for you?

• Work on impactful CSV/CSA projects ensuring patient safety & data integrity
• Join a strong expert community with knowledge sharing and mentoring
• Grow in either a leadership or technical expert career path
• Competitive and transparent package aligned with your experience

🏢 Your role

CSV Lead

• Lead end-to-end CSV/CSA projects (planning → execution → closure)
• Act as SPOC for validation teams and stakeholders (QA/IT/Business)
• Apply risk-based validation (GAMP5, CSA)
• Ensure quality deliverables, timelines and team guidance
• Represent QbD in client meetings and audits

CSV Specialist

• Execute validation for GxP systems (ERP, LIMS, MES, QMS, …)
• Create/review documentation (URS, RA, test plans, IQ/OQ/PQ)
• Perform impact & gap assessments, vendor assessments
• Support audits, inspections, change control and deviations
• Ensure compliance with Annex 11, 21 CFR Part 11, GAMP5

💪 What you bring

CSV Lead

• 8–10+ years CSV/CSA experience in GxP environments
• Strong validation & project leadership skills
• Fluent in Dutch & English

CSV Specialist

• 3–8 years CSV experience in Pharma/Biotech
• Knowledge of GAMP5, Annex 11, 21 CFR Part 11
• Fluent in Dutch & English (French is a plus)

✅ Bonus: MES validation, cloud/SaaS validation, ALCOA+, Agile/DevOps, EBR/serialization.