CSV & C&Q Lead
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Now hiring: E2E CSV/C&Q Lead | Operations Data Hub
Basel, Switzerland | 12-month contract (1 Nov 2026 - 31 Oct 2027) | Full-time, 41 hrs/week
I’m partnering with a leading life sciences manufacturer on a lead role at the center of their digital manufacturing program.
Their Operations Data Hub (ODH) connects manufacturing source systems, OT/IT integrations, platform services, data products and operational applications. They need someone to own the end-to-end validation approach that gets it ready to support GMP-relevant decision-making.
What you’ll do:
- Build and own the integrated, risk-based CSV/C&Q strategy for ODH Phase 1
- Coordinate validation delivery for the first “lighthouse” site deployment, through to release readiness
- Define the qualification approach for data products like Batch Traceability, Process Monitoring and Customer Data Sharing
- Ensure end-to-end traceability, data integrity and ALCOA+ compliance across the connected ISA-95 layers
- Shape the supplier assurance and vendor-testing reliance strategy
- Create a reusable validation blueprint, qualification archetypes and effort/cost model for future site rollouts
- Align Business, IT/OT, Automation, Engineering, Quality and external partners around one validation framework
What you bring:
- Bachelor’s or Master’s in Engineering, Automation, Computer Science, IT, Life Sciences, Pharmaceutical Sciences, Quality Management or similar
- Proven experience developing and coordinating E2E CSV/C&Q strategies for integrated systems spanning IT, OT, data platforms and applications
- Strong knowledge of risk-based validation, GMP, CSV/CSA, C&Q, change control, deviations and CAPA
- Broad understanding of automation, MES, historians, integration platforms and their validation implications
- Practical data integrity experience: data lineage, interfaces, auditability and access controls
- A pragmatic mindset, keeping things compliant and defensible without unnecessary documentation or duplicated testing
Why this one stands out: you won’t just validate a system. You’ll set the validation standard that future sites and growth projects are built on.
#CSV #CQV #ComputerSystemValidation #DataIntegrity #GMP #Validation #LifeSciences #Basel #Switzerland #Contract #Hiring
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