Senior QA Expert CSV & Data Integrity 80-100%

Lonza; Stein; Hybrid; Vertraulich; Full time

Benefits offered by this job

Relocation assistance

On-site with up to 20% remote

Competitive benefits

Job summary

Lonza Stein site invites an experienced Data Integrity Ambassador to lead DI assessments and collaborate with global colleagues to strengthen data integrity culture. You will oversee validation of computerized systems for MES (MODA) and BMS (DeltaV) and ensure ongoing compliance across production and lab equipment.

This on-site role offers flexibility to work remotely up to 20% and opportunities to influence quality systems within a growing, international team.

Qualifications

• Proven experience in Quality Assurance within GMP-regulated environments.
• Hands-on CSV validation for MES and BMS systems.
• Experience with deviation handling and change management.
• Fluent English and collaborative mindset.
• German language skills are advantageous.

Responsibilities

• Lead DI assessments and drive data integrity culture at Stein site.
• Lead CSV activities for MES (MODA), BMS (DeltaV) and equipment.
• Validate equipment/infrastructure for routine activities and CAPEX.
• Act as QA contact for CSV and lifecycle management.
• Collaborate with local/global teams on continuous improvement and audits.

Skills

Quality Assurance

GMP compliance

CSV validation

Data integrity

Stakeholder collaboration

English fluency

Tools

MODA

DeltaV

Job description

Switzerland, Stein. 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.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

Our local benefits: 3cf206339e0e4e41a77e8c806138c2b5

What You Will Do

• 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.

Reference: R78647