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 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. Flexibility to work remotely for no more than 20% of your time is offered, with requests considered on a case‑by‑case basis, in line with business needs.
Tasks
- 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.
Requirements
- 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.
Benefits
- 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, numerous lifestyle, family, and leisure benefits.
Bist du Teil dieses Unternehmens?
Dieses Unternehmensprofil wurde automatisch erstellt. Wenn du für Lonza Group AG arbeitest, kannst du das Profil jetzt beanspruchen und verifizieren – kostenlos und in wenigen Minuten.
Über uns
Das Team
You will work within a supportive international team at a growing and future-focused site, collaborating with local and global colleagues.