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CSV Lead – Basel | JobRevolt

Über den Job

Join Lonza's 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 the Operations Data Hub (ODH) Phase 1 digital transformation. Office-first role with hybrid working flexibility.

Aufgaben

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

Profil

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 systems compliance, and end-to-end requirements traceability
Demonstrated experience building reusable qualification archetypes, supplier assurance strategies, and effort models for complex global programs
Exceptional cross-functional leadership skills with the ability to bridge technical engineering, IT/OT architecture, and Quality oversight
Bachelor's or Master's degree in Engineering, Automation, Computer Science, Life Sciences, or a related discipline
Business fluency in English

Rahmenbedingungen

Contract: 12 months
Location: Basel, office-first with hybrid flexibility
Contact: Apply via Randstad (talent acquisition partner for Lonza)

Benefits

Agile career and dynamic working culture
Inclusive and ethical workplace

CSV Lead

Über den Job

Über den Job

Aufgaben

Profil

Rahmenbedingungen

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