Computer System Validation Lead & Specialist

🔍 Job Title

📍 Location: Hybrid
🕓 Type: Full-time

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
  

🏢 What you’ll be doing

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.

🫵 Who you are

Our culture is driven by values If this sounds like you, you’ll fit right in:

• You’re resilient and tackle challenges with a positive mindset

• You’re curious and always up for learning something new

• You have a no non-sense approach honest, clear, respectful

• You’re innovative and bring ideas, not just opinions

• And above all, you’re serious about your work, but not too serious about yourself

✨ About us

We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.

📩 Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.