Senior QA Expert CSV & Data Integrity 60-80%

Lonza Group; Stein (AR); Hybrid; Vertraulich; Part time

Benefits offered by this job

Global benefits

Local benefits

Job summary

Lonza Group in Stein, AG, Switzerland, invites a Data Integrity Ambassador to lead DI assessments, drive CSV activities for MES (MODA) and BMS (DeltaV), and collaborate across global teams to strengthen data integrity.

You will oversee validation activities for equipment and infrastructure, ensure GMP compliance, manage deviations and changes, and support audits in a highly regulated manufacturing environment at the site.

Qualifications

• Experience in GMP-regulated pharma environments.
• Strong understanding of pharmaceutical quality systems.

Responsibilities

• Lead DI assessments for deviations and drive compliance initiatives.
• Oversee CSV activities for MES (MODA) and BMS (DeltaV).
• Support audits/inspections and quality risk assessments.
• Collaborate with global teams to strengthen data integrity culture.

Skills

Quality Assurance

CSV knowledge

Deviations handling

Change management

Quality risk assessment

English fluency

team collaboration

Tools

MODA

DeltaV

Automation systems

Job description

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. This is a parttime 60-80% job opportunity! 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. Ready to shape the future of life sciences?

Why Lonza

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow. Join us. Be you. www.lonza.com/careers