pNow hiring: E2E CSV/CQ Lead | Operations Data Hub /ppBasel, Switzerland | 12-month contract (1 Nov 2026 - 31 Oct 2027) | Full-time, 41 hrs/week /ppI’m partnering with a leading life sciences manufacturer on a lead role at the center of their digital manufacturing program. /ppTheir 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. /ppWhat you’ll do: /pulliBuild and own the integrated, risk-based CSV/CQ strategy for ODH Phase 1 /liliCoordinate validation delivery for the first “lighthouse” site deployment, through to release readiness /liliDefine the qualification approach for data products like Batch Traceability, Process Monitoring and Customer Data Sharing /liliEnsure end-to-end traceability, data integrity and ALCOA+ compliance across the connected ISA-95 layers /liliShape the supplier assurance and vendor-testing reliance strategy /liliCreate a reusable validation blueprint, qualification archetypes and effort/cost model for future site rollouts /liliAlign Business, IT/OT, Automation, Engineering, Quality and external partners around one validation framework /li /ulpWhat you bring: /pulliBachelor’s or Master’s in Engineering, Automation, Computer Science, IT, Life Sciences, Pharmaceutical Sciences, Quality Management or similar /liliProven experience developing and coordinating E2E CSV/CQ strategies for integrated systems spanning IT, OT, data platforms and applications /liliStrong knowledge of risk-based validation, GMP, CSV/CSA, CQ, change control, deviations and CAPA /liliBroad understanding of automation, MES, historians, integration platforms and their validation implications /liliPractical data integrity experience: data lineage, interfaces, auditability and access controls /liliA pragmatic mindset, keeping things compliant and defensible without unnecessary documentation or duplicated testing /li /ulpWhy 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. /pp#CSV #CQV #ComputerSystemValidation #DataIntegrity #GMP #Validation #LifeSciences #Basel #Switzerland #Contract #Hiring /p #J-18808-Ljbffr
CSV & C&Q Lead Arbeitgeber: Panda International
Als Arbeitgeber in der pharmazeutischen Branche bieten wir Ihnen die Möglichkeit, in einem dynamischen und internationalen Umfeld in Visp, Schweiz, zu arbeiten. Unsere Unternehmenskultur fördert Zusammenarbeit und Innovation, während wir Ihnen attraktive Entwicklungsmöglichkeiten und ein wettbewerbsfähiges Gehalt von bis zu CHF 140.000 bieten. Sie werden Teil eines engagierten Teams, das an einer Vielzahl von IT-Infrastrukturprojekten arbeitet und dabei wertvolle Erfahrungen in einem regulierten Umfeld sammelt.
