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Join the 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, supporting close, real-time collaboration and team alignment, with flexibility to work remotely or at other sites.

Tasks

  • 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.

Requirements

  • 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 with strong stakeholder management and negotiation skills.

Benefits

  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Competitive hourly rate.
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Über uns
Lonza Group AG ist ein international tätiges Unternehmen für die Pharma-, Biotech- und Life-Science-Industrie. Das Unternehmen entwickelt und produziert Wirkstoffe, biopharmazeutische Produkte sowie spezialisierte Lösungen und unterstützt Kunden von der frühen Entwicklung bis zur industriellen Herstellung. Zudem stellt Lonza chemische und biotechnologische Komponenten für Anwendungen in Gesundheit, Ernährung und weiteren Industrien her.
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