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.
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