BioProcess Associate 2nd Shift

Job Title: BioProcess Associate – 2nd Shift

Location: Harvard, MA

Work Model: 100% Onsite

Shift Differential: Included

Schedule: 5:00 PM – 5:00 AM

Shift Rotation:

3 days on (Sat, Sun, Mon)

2 days off (Tues, Wed)

2 days on (Thurs, Fri)

3 days off (Sat–Mon)

Flexibility to Work Holidays Required

Experience: Minimum 1+ year in a GMP environment

Position Summary

The BioProcess Associate supports the execution of commercial manufacturing processes for therapeutic proteins following established electronic work instructions and cGMP requirements. This role is hands-on, team-oriented, and essential to maintaining high-quality production standards in a regulated cleanroom environment.

Key Responsibilities

Execute routine manufacturing activities according to written procedures and SOPs.

Recognize deviations from standard processes and escalate appropriately.

Weigh and verify raw materials; assemble, clean, and sterilize equipment.

Monitor processes and maintain a compliant cleanroom environment.

Complete electronic work instructions and production documentation.

Train to become proficient in operating core production equipment (bioreactors, chromatography systems, media/buffer prep equipment, etc.).

Gain proficiency in automation systems such as DeltaV, Syncade, PI Vision, and business systems such as SAP, Infinity, Maximo.

Assist in updating or creating SOPs and electronic work instructions.

Support inventory control for materials and components.

Maintain a safe, compliant working environment.

Education & Skills Requirements

High school diploma required.

Bachelor’s degree in science, engineering, biochemistry, or related field preferred but not required.

Strong attention to detail and personal accountability.

Experience working within teams and contributing to shared goals.

Proficiency in basic computer applications (Word, Excel, web-based systems).

Strong interpersonal and communication skills; approachable and team-focused.

Demonstrated ability to follow regulated procedures and maintain accurate records.

Work Environment & Collaboration

BioProcess Associates work closely with:

Peers and cross-functional bioprocess teams for batch coordination

Quality teams for sampling and investigation support

Materials Management for inventory and supplies

Maintenance teams for equipment support

Supervisors for daily assignments, feedback, and coaching

Occasional interactions with other management personnel for project-based needs

This role requires consistent teamwork, communication, and adherence to regulatory and safety standards.