Process Expert – Cleaning 80-100%
Core
Lead gowning, cleaning, disinfection, and labeling programs to ensure GMP compliance and operational excellence across a pharmaceutical manufacturing facility.
Role type
Senior GMP Process Expert (Cleaning & Gowning)
Builds
Cleanroom operations and contamination control programs for drug product manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP compliance, aseptic manufacturing, gowning protocols, cleaning validation, contamination control, CAPA management, audit support, stakeholder management, external vendor coordination
Preferred skills
aseptic fill & finish, compounding, equipment maintenance planning, autoclave operations
Technologies
GMP systems, cleanroom monitoring tools
Responsibilities
Lead site-wide gowning and cleaning programs; Serve as subject matter expert for cleaning processes; Coordinate external cleaning service providers; Act as primary contact for operational maintenance and shutdown activities; Partner with QA, Operations, and Engineering to optimize processes
Seniority
Senior, hands-on IC