Scope of Function: Responsible for cGMP Aseptic and automated Filling Operations; including preparation and execution of manual filling operations, automated fill line, and process qualification/validation runs according to the cGMP guidelines. Responsible for the cleaning and sterilization of items for Upstream, Downstream, and Fill Finish and Support manufacturing teams. Position will also serve as a room lead and back-up to manager.
Reports to: Manager, Fill Finish
- Perform aseptic filling operations, including but not limited to: preparation, filling, stoppering, crimping.
- Perform automated filling operations
- Technical writing for the filling group
- Cleaning of materials and equipment for use in Manufacturing, and Quality Control
- Preparation of cleaning solutions.
- Autoclave sterilization of materials and equipment for the following Manufacturing, Quality Control (QC), and support departments
- Cleaning and verification (Leak Test and Bowie-Dick Test) of the autoclaves.
- Creation and revision of standard operating procedures (SOP) and manufacturing item specifications (CP, RM, GS) as directed by Supervisor.
Education and Experience Required:
Education: Minimum of High School Diploma. Associate Degree in Science or higher education is preferred
Experience: A minimum of 3-year experience in cGMP manufacturing is preferred.
Interacts with: All Quality and Manufacturing departments. Vendors as required