Process Technician
Company: Integrated Resources, Inc
Location: Exton
Posted on: March 20, 2023
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Job Description:
Job: Process Technician Location: Exton, PA Duration: 12+ months
Pay: $30 - $35/hrs. on W2 Job details 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 Percent of Time Work in a hands-on capacity in the
operation of upstream 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 is expected. 5
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 companys 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 The individual will play a hand-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 s pipelines. Execution of manufacturing in the
GMP production suites including documenting data compliantly.
Specifically, this person will participate and contribute to the
success of the cell culture and harvest equipment operation and
processes for the manufacture of materials for global clinical
supplies. The individual will also participate in monitoring and
maintaining the production area processes to remain compliant to
regulations. The individual may also supporting a campaign and may
provide cross-functional support for other departments within the
pilot plant at the discretion of management.
Keywords: Integrated Resources, Inc, Wilmington , Process Technician, Professions , Exton, Delaware
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