Job Description
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
- Works on routine manufacturing assignments per written procedures that are complex with on instructions, where ability to recognize deviation from accepted practice is required.
- Adheres to Good Manufacturing Practices and standard operating procedures.
- Weighs and checks raw materials, assembles and cleans process equipment, monitors processes.
- Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
- Operates all production equipment (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.).
- Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).
- Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions.
- Assists with the coordination and implementation of special projects such as validation or complex investigations.
- Revises and creates process documents with no instructions, writes routine process investigations independently.
The scheduled shift for this position is 5:00PM-5:00AM EST.
Job Requirements
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent.
- A minimum of 4 years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
- Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).
- 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.
The scheduled shift for this position is 5:00PM-5:00AM EST.
Country: USA, State: Massachusetts, City: Devens, Company: Bristol-Myers Squibb.
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