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Sr. Associate Bioprocess Engineer

SR. ASSOCIATE BIOPROCESS ENGINEER
DEVENS, MA

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Shift:? 5:00 p.m. ? 5:00 a.m. (rotating schedule)
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Project Description:

  • Operates control systems and processes in Biotechnology Pilot Plants as assigned.

  • Prepares process buffers and reagents.

  • Cleans equipment and maintain area in clean and orderly fashion. Recognizes and reports safety, maintenance and operational variances to area management.

  • Communicates status of operations to area management in a timely manner.

  • Follows detailed SOP's and batch records.

  • Ensures compliance with cGMP and safety requirements.

  • Maintains files, records and equipment.

  • Records data, logs activities and monitors processes. Achieves and maintains proficiency through training.?

  • Works on routine manufacturing assignments per written procedures that are moderately complex with minimal 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 primary production equipment (i.e. bioreactors, chromatography skids, media or buffer preparation equipment 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.?


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Required Skills:

  • The successful candidate will have a high school diploma with a minimum of 5 years process operations experience A.A.S. or B.S. degree is preferred.

  • Prior job related experience required along with demonstrated mechanical aptitude.

  • Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus.

  • The nature of the position demands keen attention to detail.

  • Prior experience following and documenting written instructions is required.

  • Committed team player prepared to work in and embrace a team based culture.

  • Shift work and overtime required.

  • Selected candidates will be required to enter a structured training program and successfully complete all modules including Biologics orientation training, general knowledge training and job function training and successfully complete training module evaluations at 1, 3, 6 and 12 month milestones.

  • 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 2 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.


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This 6+ month position starts ASAP.
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Please E-MAIL your resume (attachment to email) with rate and availability to Karen: Click Here to Email Your Resum?
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ALPHA'S REQUIREMENT #18-01110
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
 

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