Process Technician (2nd Shift)

The incumbent is responsible for the execution of tasks needed to produce biopharmaceuticals under current "Good Manufacturing Practices" (cGMP) and in accordance with Standard Operating Procedures. Reporting to the Process Supervisor, the technician performs standard operating procedures, or new standard operating procedures with supervision. Performs or verifies calculations and measurements to insure that batches made maintain consistent high quality standards. Documents activity, as required, in batch records and log sheets. Work is reviewed by Process Supervisor and Quality Assurance.

- Performs standard operating procedures - May include the operation of buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved.
- Maintains process equipment according to standard operating procedures - May include clean-in-place (CIP) and steam-in-place (SIP).
- Edits/writes standard operating procedures as directed by the production supervisor - Document routing and training on revision process.
- Stocks supplies and equipment - Warehouse knowledge.
- Logs information in the sample and data tracking systems - Labware training.
- Keeps track of their own training level - Isotrain reports.
- Prepares the production area for federal, QA inspections - Thorough understanding of cGMP requirements and safety practices will be exhibited.

SKILLS:

Biopharmaceutical experience. Fermentation operations, Buffer formulation, Purification operations, Glass wash operations.