Operator I, Production
Core
Operate sterilization equipment, perform line disinfection, equipment cleaning, component transfer, and aseptic fill finish batch production in a critical cleanroom environment.
Role type
Production Operator I (Biopharmaceutical Manufacturing)
Builds
Sterile pharmaceutical products for patients
Domain
Biopharmaceuticals / Aseptic Manufacturing
Required skills
Aseptic gowning techniques, cGMP compliance, cleanroom protocols, equipment operation (isolators, filling machines, autoclaves), media fill participation, batch record documentation, visual acuity for quality assessment
Preferred skills
Technical or vocational education in pharma/biotech
Technologies
Isolators, filling machines, autoclaves, parts washers
Responsibilities
Perform aseptic processing tasks including cleaning cGMP areas and operating parts washers; Set up, calibrate, and operate aseptic processing equipment; Assist with validation of new areas and processes; Participate in aseptic process simulations, media fills, and equipment qualifications; Complete batch record documentation adhering to cGMPs; Maintain qualification to work within Grade A and Grade B environments.
Seniority
Entry-level to Junior, hands-on IC