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. 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.
Tasks
- 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.
Requirements
- 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.
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, you can expect numerous lifestyle, family, and leisure benefits.
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