CSV & C&Q Lead

CSV & C&Q Lead

Full Time Vor Ort
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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
  • Business-fluent English

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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CSV & C&Q Lead Arbeitgeber: Panda International

Panda International bietet eine dynamische Arbeitsumgebung in Visp, wo Teamarbeit und Innovation im Mittelpunkt stehen. Als Arbeitgeber fördern wir das Wachstum unserer Mitarbeitenden durch kontinuierliche Weiterbildung und spannende Projekte im Bereich der IT-Infrastruktur. Unsere Unternehmenskultur ist geprägt von Offenheit und Zusammenarbeit, was es Ihnen ermöglicht, Ihre Fähigkeiten in einem bedeutenden Sektor wie der Pharmaindustrie weiterzuentwickeln.

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Kontaktdaten:

Panda International Recruiting-Team