Process Expert – Cleaning

About the role

Take ownership of gowning and cleaning compliance across an entire GMP facility in Stein, ensuring audit‑ready processes and continuous improvement in collaboration with cross‑functional teams and external partners.

Key responsibilities

• 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.
• 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, optimise processes and contribute to strategic site‑wide improvement projects.

Required profile

• Several years of hands‑on experience in aseptic GMP manufacturing environments, ideally in Production, MSAT or QC.
• Proven expertise in gowning, cleaning, contamination control and cleanroom compliance programmes.
• Experience supporting and representing operations during customer and regulatory audits.
• Strong stakeholder‑management skills, including coordination of external service providers.
• Fluent German and English communication skills.

Required skills

• GMP compliance
• Cleanroom operations
• Contamination control
• Audit support
• CAPA management

What we offer

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programmes that recognise high performance, including a competitive salary.
• Numerous lifestyle, family and leisure benefits.