Filling Line Operator
Core
Operate and monitor aseptic Fill & Finish lines and isolators in a GMP-regulated cleanroom to produce advanced therapeutics.
Role type
Manufacturing Operator (Aseptic Fill & Finish)
Builds
Advanced therapeutics (biologics/vaccines)
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Aseptic processing, GMP compliance, Cleanroom operations, Upstream/downstream processing, Environmental monitoring, GMP documentation, Root cause analysis, CAPA management, Change control, Risk assessment
Preferred skills
Experience with isolators, APS campaigns, Qualification activities, Process improvement
Technologies
Isolators, Filling lines, Electronic batch records
Responsibilities
Prepare, set up, operate, monitor, and shut down aseptic filling lines and isolators; Perform upstream and downstream processing activities; Complete and review GMP documentation including batch records and logbooks; Support environmental monitoring and in-process controls; Participate in APS campaigns, qualification, and engineering runs; Contribute to troubleshooting, investigations, and continuous improvement activities.
Seniority
Mid-level, hands-on IC