Process Technician

Job Description

Job Summary:

• Under supervision and guidance, the 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.
• In addition, the individual will execute and participate in the execution activities for scale-up and system operations supporting the manufacture of preclinical, clinical, and commercial biologics drug substances, including operation of cell culture bioreactors and harvest equipment, GMP documentation, and ensuring compliance to relevant regulations.

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.

Education:

• Two-year Associate degree or Four-year BS in Biotechnology or (Bio)Chemical Engineering or Engineering or Biological 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.
• Ability to follow direction, work under supervision, and demonstrate capability in organizing complex activities in a cGMP production process.
• Basic skills in executing routine production, maintenance, and operation of upstream cell culture and harvest equipment.
• Must have a Mechanical aptitude.
• Good aseptic technique in maintaining process sterility.
• Good written, communication, and interpersonal skills with the ability to work in a team environment required.
• Capabilities in the operation of all area-specific production equipment such as large scale stir tank and/or single-use disposable bioreactors, centrifuge, micro-filtration, and CIP/SIP operations is a plus.
• Previous exposures to cGMP, EMEA, and JP regulations as a plus.