Process Expert - Cleaning 80-100%

Lonza Group Ltd.; Stein; On-site; Confidential; Full time

Benefits offered by this job

Competitive salary

Lifestyle and leisure benefits

Global benefits program

Job summary

Lonza Group Ltd. in Stein, Switzerland, is seeking an experienced GMP professional to lead gowning, cleaning and containment programs to ensure site-wide quality and compliance.

You will coordinate external cleaning providers, support audits, CAPAs and continuous improvement, and work closely with MSAT, QA, Operations and Engineering to optimize processes. Fluent German and English are required, with aseptic manufacturing experience highly valued.

Qualifications

• Hands-on experience in aseptic GMP manufacturing environments.
• Experience with gowning, cleaning and contamination control and cleanroom compliance.
• Experience supporting audits and regulatory inspections; ability to present processes in inspection-ready environments.
• Stakeholder management including coordinating external service providers and cross-functional partners.
• Fluent German and fluent English; familiarity with aseptic fill & finish is a plus.

Responsibilities

• Lead and enhance gowning, cleaning, disinfection, labeling and identification programs to ensure GMP compliance and operational excellence.
• Serve as SME for cleaning and gowning processes, supporting audits, CAPAs and continuous improvement.
• Coordinate and oversee external cleaning service providers, ensuring training compliance and performance.
• Act as primary contact for operational maintenance and shutdown activities to drive cleanliness zoning and contamination control.
• Partner with MSAT, QA, Operations and Engineering to implement compliance concepts and optimize processes.

Skills

Gowning and cleaning processes

GMP manufacturing experience

Audit support

CAPA and continuous improvement

Cross-functional collaboration

German language

English language

Job description

Location

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

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.