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Bio Process Associate (Overnight Shift)
Ref No.: 18-17146
Location: Devens, Massachusetts
Job Description: 2nd Shift Bio Process Senior Associate

2nd Shift: 5pm-5am

1. 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.
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 primary production equipment (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.) as instructed.
6. 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.
7. Revises and creates process documents with little to no instruction, assists with process related investigations.

• 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

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.
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.