Bioprocess Specialist, Process Support - Night Shift

Bioprocess Specialist, Process Support - Night Shift

Title: Bioprocess Specialist, Process Support - Night Shift
Location: NA-US-MA-Devens

Bioprocess Specialists will work in teams and have continual interaction with members of his/her team as well as other bioprocess teams throughout the manufacturing process in order to exchange information regarding the batch(s) in process. In addition there will be frequent contact with members of the Quality department with regard to inline sampling and variance investigation. Lesser but also important are interactions with Materials Management and Maintenance staff for supplies and repair of equipment. All Bioprocess Associates/Specialists will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions. Occasional contact with other line management staff relating to specific project responsibilities may be expected. 1. Works on routine manufacturing assignments per written procedures that are complex with on instructions, where ability to recognize deviation from accepted practice is required. 2. Adheres to Good Manufacturing Practices and standard operating procedures. 3. Weighs and checks raw materials, assembles and cleans process equipment, monitors processes. 4. Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements. 5. Operates all production equipment (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.). 6. 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.). 7. Ensures less experienced manufacturing personnelcomply with Standard Operating Procedures (SOPs) and electronic work instructions. 8. Assists with the coordination and implementation of special projects such as validation or complex investigations. 9. Revises and creates process documents with no instructions, writes routine process investigations independently.
. 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 participationon 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 : Manufacturing Operations