Job Title
đź“Ť Location: Hybrid
đź•“ 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)
âś… 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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