Senior Sterile Manufacturing Operator 503B
Core
Execute advanced aseptic manufacturing activities to ensure safe, accurate, and reliable production of sterile medications in a highly regulated 503A/503B environment.
Role type
Senior Sterile Manufacturing Operator
Builds
Sterile medications for patients nationwide
Domain
Pharmaceutical manufacturing / Aseptic processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic technique, sterile equipment operation, cleanroom gowning, component preparation, autoclave use, bubble point testing, regulatory compliance (21 CFR, USP), documentation accuracy, issue resolution, process improvement
Preferred skills
Aseptic processing certification, cleanroom certification, technical coursework in sterile manufacturing
Technologies
Autoclaves, sterile processing equipment, cleanroom environmental controls
Responsibilities
Execute advanced sterile manufacturing activities using qualified aseptic techniques; Operate sterile processing equipment accurately; Prepare components and perform bubble point testing; Follow 21 CFR Parts 210/211 and USP Chapters 797/800; Perform cleaning, disinfection, and sterilization of components and work areas; Complete production records accurately and contemporaneously; Identify production issues and escalate concerns; Reinforce proper sterile processing techniques with developing operators
Seniority
Senior, hands-on IC