Senior QA Expert CSV & Data Integrity 80-100%

Lonza Group Ltd.; Stein (AR); Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Relocation assistance

Remote work up to 20%

Zusammenfassung

Lonza Group Ltd. is seeking a Data Integrity Ambassador for the Stein site to lead DI assessments and drive compliance across manufacturing and lab environments.

You will validate MES (MODA) and BMS (DeltaV) systems, manage CSV activities, and ensure inspection-ready state throughout lifecycle while collaborating with global teams.

Qualifikationen

• Proven QA experience in GMP-regulated environment.
• Hands-on Computerized System Validation (CSV) expertise.
• Lifecycle validation of MES, BMS and automation systems.
• Fluent English; German language skills advantageous.

Aufgaben

• Lead Data Integrity assessments and drive compliance initiatives with global stakeholders.
• Handle Computerized System Validation (CSV) activities for MES (MODA) and BMS (DeltaV).
• Oversee validation of equipment/infrastructure for routine and CAPEX projects per GMP and Lonza standards.
• Act as the key QA contact for CSV and guide document lifecycle management and risk assessment.
• Collaborate with local and global teams to foster continuous improvement and support audits.

Kenntnisse

Quality Assurance

GMP Compliance

Data Integrity

CSV Validation

Cross-functional

Ausbildung

Bachelor's degree in a life sciences or related field

Tools

MODA

DeltaV

MES

BMS

Jobbeschreibung

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.