Process Technician of Upstream Operations will be responsible for hand-on executing the routine operation, maintenance, and periodically requalification of cell culture based upstream production equipment and production suites in a cGMP biopharmaceutical pilot plant.
Responsibilities:
Work in a hands-on capacity in the operation of upstream equipment for the manufacture of preclinical, clinical, and commercial biologics drug substances.
Ability to follow oral and written instructions, maintain neat, accurate, and current training and cGMP records.
Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.
Perform process performance sampling/ in process testing supporting the manufacturing.
Maintains, inventories, and transports all required equipment, materials, supplies and products. Some heavy lifting is expected.
Participate and contribute in the validation maintenance, re-qualification of upstream (cell culture and harvest) production equipment. Assist and contribute in the commissioning of new equipment for upstream manufacturing. Participation in other areas within the facility may be added at the company's discretion.
Assist in equipment maintenance and calibration with appropriate internal departments. Provide cross-functional support for other departments within the pilot plant at the discretion of management.
Education: Two-year Associate degree or Four-year BS in Biotechnology or (Bio)Chemical Engineering or Engineering orBiological Sciences or equivalent job experience/degree is strongly preferred.
Experience:
Minimum of 2-4 year (Associate degree) or 0-2 year (BS) practical scientific experience.