Job Details

  • Title: Bio Process Associate
  • Code: RCI-BMS-28650-1
  • Location: Devens Massachusetts (MA) 01434
  • Posted Date: 09/10/2019
  • Duration: 6 Months
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  Job Description

1st Shift Rotating Days Position - 5:00 am to 5:00 pm

  • The Bioprocess Associate assists in the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).
  • Works on routine manufacturing assignments per written procedures that are moderately complex with minimal instructions, where the ability to recognize deviation from accepted practice is required.
  • Adheres to Good Manufacturing Practices and standard operating procedures.
  • Assembles, cleans and sterilizes process equipment, monitors processes.
  • Completes electronic work instructions and maintains a clean room environment to comply with regulatory requirements.
  • Operates primary production equipment within the assigned functional area (i.e. media prep, dispensary, bioreactor, harvest, etc.) as instructed.
  • Effectively uses in process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo, etc.) to maintain production records.
  • Revises and creates process documents with little to no instruction, assists with process related investigations.
  • Leads in maintaining material and components inventory level.
  • Assists with reviewing batch and exception reports associated with each manufacturing lot, in conjunction with supervisor and Quality representative.
  • Provide assistance for areas specific initiatives associated with work safety.

Qualifications

  • A high school diploma is required.
  • Prior experience with Good Manufacturing Practices (GMP) regulations and/or prior work experience in a clean room or highly regulated environment a plus.
  • Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
  • Demonstrated proficiency in common computer tools such as word processing, spreadsheet, and web-based applications.
  • Previous work experience where attention to detail and personal accountability were critical to success.
  • Demonstrates good interpersonal skills, is attentive and approachable.
  • Maintains a professional and productive relationship with area management and co-workers.