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CSV Lead

Lonza Group AG

Suiza📅 7/10/2026

Descripción

**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 understanding of data integrity principles (ALCOA\+), computerized
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