Process Expert – Cleaning 80-100%

Lonza; Stein am Rhein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Competitive salary

Lifestyle benefits

Family benefits

Zusammenfassung

Lonza in Stein am Rhein is seeking an experienced GMP gowning and cleaning specialist to drive site-wide compliance and continuous improvement. You will lead gowning, cleaning, disinfection and labeling programs, support audits, CAPAs and cross-functional projects to maintain the highest quality and safety standards.

This fully site-based role requires hands-on experience in aseptic manufacturing, strong knowledge of cleanrooms, and the ability to collaborate with MSAT, QA, Operations and

Qualifikationen

• Hands-on experience in aseptic GMP manufacturing environments.
• Strong understanding of cleanroom operations and compliance programs.
• Proven expertise in gowning, cleaning and contamination control.

Aufgaben

• Lead site-wide gowning, cleaning, disinfection, labeling and identification programs to ensure GMP compliance.
• Act as SME for cleaning and gowning processes and support audits, inspections and CAPAs.
• Coordinate external cleaning service providers and ensure training and performance alignment with quality standards.
• Serve as primary contact for maintenance and shutdown activities, driving contamination control and cross-functional coordination.
• Partner with MSAT, QA, Operations and Engineering to implement compliance concepts and drive site-wide improvements.

Kenntnisse

Aseptic GMP

Cleanroom operations

Gowning

Cleaning

Audit support

MSAT collaboration

Jobbeschreibung

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

Take ownership of gowning and cleaning compliance across an entire GMP facility, ensuring MSAT concepts are effectively implemented on the shopfloor, audit-ready and continuously improved in collaboration with cross-functional teams and external partners. As a key subject matter expert you will drive investigations, present concepts during audits and contribute directly to operational and site‑wide cleaning excellence initiatives. Check out Your Career in Drug Product Services at Lonza !

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

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.

Lead and continuously enhance site-wide gowning, cleaning, disinfection, labeling and identification programs to ensure GMP compliance and operational excellence.

Serve as the subject matter expert for cleaning and gowning processes, supporting audits, inspections, investigations, CAPAs and continuous improvement initiatives across the facility.

Coordinate and oversee external cleaning service providers, ensuring training compliance, performance management and alignment with site quality standards.

Act as the primary point of contact for operational maintenance and shutdown activities, driving cleanliness zoning, contamination control and cross-functional coordination.

Partner with MSAT, QA, Operations and Engineering teams to implement compliance concepts, optimize processes and contribute to strategic site-wide improvement projects.

What we are looking for:

Several years of hands‑on experience in aseptic GMP manufacturing environments, ideally in Production, MSAT or QC with a strong understanding of cleanroom operations and the practical implementation of compliance concepts.

Proven expertise in gowning, cleaning, contamination control and cleanroom compliance programs with the ability to drive investigations, CAPAs and continuous improvement initiatives.

Experience supporting and representing operations during customer and regulatory audits with the confidence to present processes, concepts and compliance measures in an inspection‑ready environment.

Strong stakeholder management skills including coordinating external service providers and contingent workforce teams, while effectively collaborating with QA, Operations, Engineering and other cross‑functional partners.

Fluent German and fluent English communication skills are essential; experience in aseptic fill & finish, compounding, equipment maintenance planning, autoclave operations is considered an advantage.

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.