Sr. Associate Bioprocess Engineer


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

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.

This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Karen: Click Here to Email Your Resum?

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Sr. Associate, Gene Therapy Upstream (18-277)
Andover, MA Sarepta Therapeutics
Sr Associate II, Site Planning
Cambridge, MA Biogen Idec
Senior BioProcess Engineer - Downstream
Burlington, MA Millipore Sigma
Sr. Associate, QC Microbiology
Cambridge, MA Moderna Theraputics
Sr Softw Dev Engineer
Burlington, MA Aetna Inc.