GMP Cleaning & Gowning Specialist (MSAT & Audits)

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

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.