Hybrid CSV/C&Q Lead: Global Validation Architect

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

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.