Bio Process Associate - # 26-26441

US Tech Solutions•Devens, MA

About The Position

The Bio Process Associate performs routine manufacturing assignments according to written procedures and must recognize deviations from accepted practices. The role follows Good Manufacturing Practices (GMP) and standard operating procedures in a large-scale cell culture facility with classified areas. Associates work in teams and communicate throughout the manufacturing process to exchange information about batches. They also interact with Quality regarding inline sampling and variance investigations, and with Materials Management and Maintenance for supplies and equipment repairs. Daily contact with supervisory staff includes work assignments, coaching, and management discussions; occasional contact with other line management may relate to specific projects. The position is a three-month assignment with the possibility of extension. The shift is 5 p.m. to 5 a.m., on a rotating schedule: three days on (Saturday–Monday), two days off (Tuesday–Wednesday), two days on (Thursday–Friday), followed by three days off (Saturday–Monday). Work takes place in a state-of-the-art large-scale cell culture facility and requires appropriate personal protective equipment (PPE). The role may involve contact with hazardous materials such as caustic substances and steam.

Requirements

High school diploma.
Demonstrated proficiency with common computer tools, including word processing, spreadsheet, and web-based applications.
Prior work or study experience demonstrating attention to detail and personal accountability.
Good interpersonal skills; attentive and approachable.
Ability to maintain professional and productive relationships with area management and coworkers.
Prior evidence of successful participation on work/study teams where collaboration, combined contributions, and results were expected.

Nice To Haves

Knowledge of science generally attained through studies resulting in a B.S. 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.
Follow Good Manufacturing Practices and standard operating procedures.
Weigh and check raw materials.
Assemble, clean, and sterilize process equipment, and monitor processes.
Complete electronic work instructions and maintain a clean-room environment in compliance with regulatory requirements.
Train to proficiency in primary production equipment in the assigned functional area, such as bioreactors and media or buffer preparation equipment.
Train to proficiency in process automation systems, including Delta V, Syncade Interactions, and OSI/Pi Historian, and supporting business systems such as SAP, Vault, and Maximo.
Assist with revising or creating process documents, including SOPs and electronic work instructions.
Assist in maintaining inventory levels for materials and components.
Support a safe work environment.
Communicate with team members and other bioprocess teams regarding batches in process.
Coordinate with Quality on inline sampling and variance investigations, and with Materials Management and Maintenance regarding supplies and equipment repairs.