Senior Bioprocess Associate - Devens MA

VetJobs•Devens, MA

11d•$30 - $36•Onsite

About The Position

The Senior Bioprocess Associate uses current Good Manufacturing Practices (cGMPs) to execute commercial manufacturing processes for therapeutic proteins used in medicines. The role performs moderately complex routine manufacturing work under written procedures, with minimal instruction, and requires recognizing deviations from accepted practices. It operates production equipment, supports process documentation and investigations, maintains production records, and contributes to safe and compliant manufacturing operations.

Requirements

High school diploma required.
At least 2 years of process operations experience in a biotechnology manufacturing facility subject to GMP regulations.
Practical knowledge of regulations such as GMP and company Standard Operating Procedures.
Experience participating successfully in work teams where personal accountability, attention to detail, collaboration, and results were expected.
Proficiency with common computer tools, including word processing, spreadsheet, and web-based applications.
Previous work experience where attention to detail and personal accountability are critical to success.
Good interpersonal skills; attentive and approachable.
Ability to maintain professional and productive relationships with area management and coworkers.

Nice To Haves

Knowledge of science generally attained through a bachelor's degree in science, engineering, biochemistry, or a related discipline, or equivalent; desired but not required.

Responsibilities

Perform routine manufacturing assignments according to written procedures and recognize deviations from accepted practices.
Adhere to Good Manufacturing Practices and standard operating procedures.
Revise and create process documents, including SOPs and batch records, and assist with process-related investigations.
Train to proficiency in process automation, supporting business systems, and primary production equipment within the assigned functional area.
Operate primary production equipment, such as bioreactors, chromatography skids, and media or buffer preparation equipment, as instructed.
Lead in maintaining material and component inventory levels.
Support a safe work environment and contribute to area-specific safety initiatives.
Weigh and check raw materials; assemble, clean, and sterilize process equipment; and monitor processes.
Complete work instructions and maintain a clean-room environment in compliance with regulatory requirements.
Use in-process automation systems, including Delta V, Syncade Interactions, and OSI/Pi Historian, and supporting business systems such as SAP, Trackwise, and Maximo to maintain production records.
Assist with reviewing batch and exception reports for each manufacturing lot in conjunction with a supervisor and Quality representative.