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Bioprocess Specialist
Ref No.: 17-01520
Location: Devens, Massachusetts
Position Type:Contract
Start Date / End Date: 11/13/2017 to 05/12/2018

Shift: 5 am-5 pm - Two days on, two days off three days on every other week

Project Description:
The Bioprocess Specialist assists in the execution of commercial manufacturing process according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMP's). Candidate needs to be able to fit in with the 14 people group. Must be willing to learn and take direction as well as perform job responsibilities independently. Will be working with a lot of experienced individuals and must be able to switch gears and work well within a Manufacturing environment.
  • Works on routine manufacturing assignments as well as assignments that are complex in nature where action and a high degree of initiative are required in resolving problems and making recommendations.
  • 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 and systems to support biologics production of downstream unit operations (i.e. glass washers, Buffer equipment, chromatography skids, membrane operations, column packing skids, etc.)
  • Effectively uses and possess mastery for 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 and that training is completed on time.
  • Under direction of supervisor or Technical SME, leads 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 independently.
  • Reviews batch and exception reports for each manufacturing lot in conjunction with Quality representative. Follows through exceptions and resolves issues. Also assists with developing CAPAs. Develops CAPA as necessary to expedite lot release.
  • 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. Advises Shift supervisor on improvements which may optimize work processes. Works on Routine manufacturing.
  • Functional specifications will be developed for automation code associated with Delta V units and phases, and will include functional descriptions. Documents will include interlocks, phase tables, equipment modules, control modules, and all associated parameters.
  • Functional specifications are also required for Syncade recipes; these will be high level and will include batch record requirements and process related parameters. Will also document required critical and process parameters associated with a particular process step.

Required Skills:
  • 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.
  • Willing to hire a college graduate with less experience if right candidate.
  • A minimum of 5 years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
  • Strong knowledge of 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.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Patrick: