| 100% onsite Work Schedule: Shift rotation: 3 days on (Sat, Sun, Mon), 2 days off (Tues, Wed), 2 days on (Thurs, Fri), 3 days off (Sat to Mon). Required to work on holidays and weekends as scheduled Key Responsibilities: " 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, cleans and sterilizes process equipment, monitors processes. " Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements. " Operates all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, 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, supports routine process investigations. " Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative. " Champions areas specific initiatives associated with work safety. " Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment. Qualifications & Experience: " High school diploma is required. Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is desired but not required. " A minimum of 1 + years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations. " Strong knowledge of either upstream and/or downstream unit operation is essential. " 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 " Maintains a professional and productive relationship with area management and co-workers. | |
| Additional Job Requirements: | Lab w/o blood & animal Position Handles Hazardous Materials |
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| Location | Devens, MA |
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