Senior QA Expert CSV & Data Integrity 80-100%

Lonza; Stein; Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Competitive salary

Lifestyle & leisure benefits

Zusammenfassung

Lonza Stein in Switzerland seeks a Senior QA Expert CSV & Data Integrity to lead DI initiatives on-site, driving compliance for computerized systems and validation for MES and BMS. You will collaborate with global colleagues to ensure regulatory readiness and robust data integrity culture.

The role emphasizes on-site work with up to 20% remote time, enabling precise, real-time collaboration to support manufacturing of medicines at the highest quality standards in a growing site.

Qualifikationen

• Experience in QA within GMP-regulated environments.
• Expertise in CSV for MES and BMS systems.
• Strong deviation handling, change control and risk assessment skills.
• Fluent English; German is advantageous in regulatory contexts.

Aufgaben

• Act as Data Integrity Ambassador for the Stein site, leading DI assessments and driving compliance improvements.
• Lead validation activities for MES (MODA), BMS (DeltaV) and production/lab equipment lifecycle.
• Oversee computerized system validation for equipment and infrastructure, including CAPEX projects.
• Serve as the key QA contact for CSV, guiding validation strategies and documentation lifecycle.
• Collaborate with local/global teams to support audits, deviations, CAPAs and change controls.

Kenntnisse

Quality Assurance

GMP compliance

CSV

Deviation handling

Change management

Quality risk assessment

English proficiency

German language (advantage)

Tools

MODA MES

DeltaV

Jobbeschreibung

Senior QA Expert CSV & Data Integrity 80-100%

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

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. You will also play a key role in the validation of computerized systems for production and laboratory equipment, including validation of Manufacturing Execution Systems (MES e.g. MODA) as well as Building Management Systems (BMS e.g. DeltaV), within a supportive international team at a growing and future-focused site. Check out Your Career in Drug Product Services at Lonza !

This role is primarily based on site. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case-by-case basis, in line with business needs.

What you will get:

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

• Serve as the Data Integrity (DI) Ambassador for the Stein manufacturing site , leading DI assessments for deviations, driving compliance initiatives, and collaborating with global stakeholders to strengthen the site's data integrity culture.
• Lead and maintain Computerized System Validation (CSV) activities for MES (e.g. MODA), BMS (e.g. DeltaV) as well as production and laboratory equipment, ensuring systems remain compliant, qualified, and inspection-ready throughout their lifecycle.
• Oversee validation of computerized systems for equipment and infrastructure for routine activities as well as CAPEX Projects ensuring adherence to validation master plans, GMP requirements, and Lonza quality standards.
• Act as the key QA contact for CSV , providing expert guidance on validation strategies, document lifecycle management, compliance matters, and quality risk assessments.
• Partner with local and global teams to drive continuous improvement , support audits and inspections, manage deviations, CAPAs and change controls for routine as well as CAPEX Project activities and contribute to the development of robust quality and data integrity practices across the site.

What we are looking for:

• Proven experience in Quality Assurance within a GMP-regulated environment , with a strong understanding of pharmaceutical quality systems and relevant compliance requirements.
• Hands-on expertise in Computerized System Validation (CSV) , including the validation and lifecycle management of MES, BMS and automation systems such as MODA, DeltaV or similar platforms.
• Solid experience in deviation handling, change management, and quality risk assessment , with the ability to drive compliant and effective solutions.
• Fluent English skills and a collaborative, team-oriented mindset , enabling successful work in an international environment and effective partnership with cross-functional and global stakeholders.
• Experience in Data Integrity, health authority inspections and audits (e.g., FDA, Swissmedic), and German language skills are advantageous , helping you excel in a highly regulated manufacturing setting.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.