Senior QA Expert CSV & Data Integrity (60-80%)

About the role

You will serve as the Data Integrity (DI) Ambassador for the Lonza Stein manufacturing site, leading DI assessments, collaborating with global colleagues, and driving a strong culture of compliance and data integrity. The role also includes validation of computerized systems for production and laboratory equipment.

Key responsibilities

• Lead DI assessments for deviations and drive compliance initiatives across the site.
• Maintain Computerized System Validation (CSV) activities for MES (e.g., MODA), BMS (e.g., DeltaV) and related equipment.
• Oversee validation of computerized systems for routine activities and CAPEX projects, ensuring adherence to GMP and Lonza quality standards.
• Act as the primary QA contact for CSV, providing guidance on validation strategies, document lifecycle management, and quality risk assessments.
• Partner with local and global teams to support audits, inspections, deviations, CAPAs, and change controls.

Required profile

• Proven QA experience in a GMP‑regulated pharmaceutical environment.
• Hands‑on expertise in CSV, including lifecycle management of MES, BMS and automation platforms.
• Solid background in deviation handling, change management and quality risk assessment.
• Fluent English and a collaborative mindset; German language skills are a plus.

Required skills

• Computerized System Validation (CSV)
• MES (e.g., MODA)
• BMS (e.g., DeltaV)
• GMP compliance
• Data Integrity principles

What we offer

• Agile career and dynamic work culture
• Inclusive and ethical workplace
• Compensation programs that recognize high performance
• Competitive salary with lifestyle, family and leisure benefits