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Job: Industrial Process Specialist II, Medicago USA, Durham, NC

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General Information


Job title: Industrial Process Specialist II
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Job location: Durham, NC  27713 United States
Requisition code:
Date posted: 03/12/2018
Job category:Manufacturing and Production
Employment type:Full time
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Job Description

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Under the supervision of the Upstream/Downstream Process Manager or Supervisor, the candidate is responsible for the execution of activities for biopharmaceutical production. Responsibilities involve day-to-day ongoing biopharmaceutical production, documentation and process efficiency improvements.

• Execution of production processes to meet manufacturing and business requirements
• Involved in process scale-up, process optimization and process validation activities
• Adhering to and development of documentation, including standard operating procedures and batch records
• Coordinates inventory of consumables for production
• Supports the generation and resolution of process deviations
• Inspect and maintain the production equipment and control systems
• Collaborates with process support and development groups to assure smooth process transition in manufacturing
• Support department management in developing and providing training for the process floor
• Inputs, reviews, and trends batch production data to support campaign summary report completion
• Ability to work flexible schedules during process start-up and ongoing operations
• Maintain company safety, health and environmental standards
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Job Requirements

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• In-depth understanding of cGMP compliant production and documentation
• Able to function in a fast-paced team environment to meet critical production timelines
• Experienced with process equipment and systems, including 1 or more of the following: Fermentation, Ultrafiltration, Chromatography (Unicorn®), Centrifugation, Aseptic Practices and Dispensing, Material Handling, Depth Filtration.
• Experience with flexible/disposable single-use systems and technology transfers are a plus
• The employee is occasionally required to stand, up to 6 hours a day; walk; reach with hands and arm and stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 50 pounds.

• Requires a technical degree with a minimum of 3 years’ experience or University degree with a minimum of 2 years’ experience or equivalent.
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