CSV Lead

--- base: / meta-keywords: meta-viewport: width=device-width, initial-scale=1.0 ---   CSV Lead ======== CSV (C&Q) Lead Join our Global Engineering team in Basel on a 12-month contract to define, coordinate, and deliver the integrated commissioning, qualification, and computer systems validation (CSV/C&Q) framework for Lonza's Operations Data Hub (ODH) Phase 1 digital transformation. This is an office-first role with hybrid working. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely/other sites What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. What you will do: Drive the overall digital transformation impact by establishing a reusable validation blueprint and qualification archetypes for global site scale-out. Lead cross-functional alignment across Business, Engineering, Automation, IT/OT, Application, and Quality workstreams. Define and execute the end-to-end integrated CSV/C&Q strategy across all ISA-95 layers, spanning source OT systems, cloud platforms, and data products. Coordinate qualification and validation delivery for the Portsmouth Midscale Lighthouse production deployment. Assess and ensure complete requirements traceability, GxP compliance, ALCOA+ data integrity, and auditability across all connected architectures. Establish validation effort, schedule, and cost models to support long-term rollout planning and budget estimation. Provide pragmatic, risk-based validation leadership that balances regulatory compliance with operational speed and agility. What we are looking for: 10+ years of proven experience leading integrated CSV and C&Q delivery in regulated life sciences or pharmaceutical environments. Extensive expertise in risk-based validation (GAMP 5, CSA/CSV) across connected IT/OT infrastructure, automation, MES, and enterprise data platforms. Deep un