Posted on: January 25, 2023
Job Title: Process Technician
Job Location: Exton - PA
Job Duration: 12 Months of Contract
- 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 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.
- 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 to the validation maintenance,
re-qualification of downstream production equipment. Assist and
contribute to the commissioning of new equipment for downstream
- 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%
- 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 client 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
- The individual may also support a campaign by providing
cross-functional support for other departments within the pilot
plant at the discretion of management.
- Experience with Downstream and Purification processing
- GMP experience
- 1 yr. experience in pharmaceutical, biotech (including
internship and/or co-op)
- Potential exposure to laboratory assignments (mixture of GMP
and laboratory experience OK but some GMP 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
- Basic skills in executing routine production, maintenance, and
operation of downstream equipment.
- Must have a Mechanical aptitude.
- Good aseptic technique in maintaining process
- 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
- Exposure to data historian interfaces (eg Wonderware) a
- 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
- -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.
Keywords: Atlas, Wilmington , Process Technician, Professions , Exton, Delaware
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