Goodwin Biotechnology

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

Responsibilities:

  • 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