Bioprocess Associate (1st shift) (Onsite- Devens, MA)

Responsibilities

• Works on routine manufacturing assignments per written procedures that are complex with on instructions, where ability to recognize deviation from accepted practice is required.
• 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 within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.).
• Effectively uses 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.
• Assists with 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.
• Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative.
• 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.

Requirements

• A minimum of 1 + years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
• Strong knowledge of either upstream and/or downstream unit operation is essential.
• 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.
• A 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.

Benefits

• Health benefits
• 401K

Pay

$28/hr. - $30.67/hr.

Schedule

Shift rotation: 3 days on (Sat, Sun, Mon), 2 days off (Tues, Wed), 2 days on (Thurs, Fri), 3 days off (Sat to Mon).