CSV Lead

•

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:

What you will do:

What we are looking for:

About Lonza At Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work they want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment. As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role. Ready to play your part in shaping the future of life sciences? Apply now.

Münchensteinerstrasse 38 4052 Basel

•

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• 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.
• 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.
• Lonza Group AG