Process Expert – Cleaning 80-100%

Lonza; Stein (AR); Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Stein, Switzerland is seeking a site-based expert to own gowning, cleaning and disinfection programs across a GMP facility, driving audit readiness and continuous improvement in collaboration with MSAT, QA, Operations and Engineering.

The role emphasizes external provider coordination, training compliance and contaminations control, with a strong focus on delivering high-precision pharmaceutical manufacturing standards on-site.

Qualifikationen

• Several years of hands-on experience in aseptic GMP manufacturing environments.
• Proven expertise in gowning, cleaning, contamination control and cleanroom compliance.
• Experience supporting audits and driving CAPAs.
• Fluent German and English; aseptic fill/finish experience is a plus.

Aufgaben

• Lead and continuously enhance 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.
• 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.

Kenntnisse

Gowning

Cleaning

Contamination control

Audit readiness

Stakeholder management

Tools

Autoclave operations

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.

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:

• 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.