Computer System Validation

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.

• 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
  

• 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

• 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

• 8–10+ years CSV/CSA experience in GxP environments

• Strong validation & project leadership skills

• Fluent in Dutch & English

• 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.

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

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.