210 Welsh Pool Rd Exton, PA 19341 US
Pay Rate: 20-23.40/hr **salary will be commensurate with experience
Under supervision and guidance, the Process Technician / Associate of Downstream Operations will be responsible for hands-on execution of routine operations supporting the manufacture of preclinical, clinical, and commercial biologics drug substances as well as assistance with general upkeep of downstream processing suites in a cGMP biopharmaceutical pilot plant. Responsibilities will include operation of chromatograph columns, process skids, and UFDF equipment, GMP documentation, and ensuring compliance to relevant regulations. Additional responsibilities may include assistance with maintenance and periodic requalification of downstream production equipment as well as participation in activities related to the scale-up of downstream processes and occasional laboratory scale work.
The individual will play a hands-on execution role in the routine operation of the Biological pilot plant whose purpose is to produce material for preclinical, clinical, and commercial biologics drug substance to support pipelines. Execution of manufacturing in the GMP production suites including documenting data according to good documentation practices.
Specifically, this person will participate and contribute to the success of the downstream equipment operation and processes for the manufacture of materials for global clinical supplies. The individual will also participate in monitoring and maintaining the production processes to ensure compliance to current regulations. The individual may also support a campaign by providing cross-functional support for other departments within the pilot plant at the discretion of management.
- Work in a hands-on capacity in the operation of downstream equipment for the manufacture of preclinical, clinical, and commercial biologics drug substances. 25%
- Ability to follow oral and written instructions, maintain neat, accurate, and current training and cGMP records. 20%
- Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices. 20
- Perform process performance sampling/ in process testing supporting the manufacturing. 20%
- Maintains, inventories, and transports all required equipment, materials, supplies and products. Some heavy lifting (up to 40 pounds) is expected. 5%
- Participate and contribute in the validation maintenance, re-qualification of downstream production equipment. Assist and contribute in the commissioning of new equipment for downstream manufacturing. Participation in other areas within the facility may be added at the company’s discretion. 5%
- 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. 5%
- 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.
- 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 downstream 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.
- Basic computer skills including use of MS Excel and Word required. Exposure to data historian interfaces (eg Wonderware) a plus
- Capabilities in the operation of all area-specific production equipment such as large scale chromatograph columns, process skids, and UFDF equipment operations is a plus.
- Previous exposure to cGMP, EMEA, and JP regulations preferred.
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