CSV (C&Q) Lead

Lonza; Basel; Hybrid; Vertraulich; Full time

Benefits offered by this job

An agile career and dynamic workingc

Job summary

Lonza Basel is hiring for a 12-month contract to define, coordinate, and deliver the integrated CSV/C&Q framework for the ODH Phase 1 digital transformation. The role requires 10+ years in regulated life sciences and a strong track record in validation leadership, data integrity, and ALCOA+.

Work is office-first with hybrid options, collaboration across IT/OT, Engineering, and Quality, and a focus on scalable, compliant validation solutions.

Qualifications

• 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 IT/OT, automation, MES, and data platforms.
• Deep understanding of data integrity principles (ALCOA+), computerized systems compliance, and traceability.

Responsibilities

• Drive the 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 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.

Skills

Cross-functional leadership

Risk-based validation

Data integrity ALCOA+

Qualification archetypes

Stakeholder management

English fluency

Education

Bachelor’s or Master’s degree in Engineering

Job description

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 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.

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?