Bio Process Associate

TSR is a relationship-based, customer-focused staffing company. For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.
Industry: Pharmaceutical
One of our most prestigious clients is looking for a Bio Process Senior Associate. This is a long term opportunity located in the Devens MA area.
Skills required:
Work on routine manufacturing assignments per written procedures that are moderately complex with minimal instructions, where ability to recognize deviation from accepted practice is required
Adhere to Good Manufacturing Practices and standard operating procedures
Weigh and check raw materials, assemble and clean process equipment, monitors processes
Complete electronic work instructions and maintains clean room environment to comply with regulatory requirements
Operate primary production equipment (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.) as instructed
Effectively use 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
Revise and create process documents with little to no instruction, assist with process related investigations
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)
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications
Operate control systems and processes in Biotechnology Pilot Plants as assigned
Prepare process buffers and reagents
Clean equipment and maintain area in clean and orderly fashion
Recognize and reports safety, maintenance and operational variances to area management
Ensure compliance with cGMP and safety requirements
Maintain files, records and equipment
Record data, logs activities and monitors processes
Achieve and maintain proficiency through training
Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus

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