Manufacturing Associate 3, Upstream/Downstream

Fujifilm•Holly Springs, NC

11h

About The Position

The Manufacturing Associate 3 assists with executing and documenting manufacturing processing activities in a cGMP environment. The role supports project-phase readiness and steady-state operations at a 24/7 biopharmaceutical manufacturing facility, helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required. The position contributes to operational readiness, including procedure creation, process transfer, equipment testing, commissioning, and validation. It independently performs and documents manufacturing activities according to SOPs and cGMP requirements, conducts process monitoring and in-process testing, operates assigned production equipment, and supports troubleshooting and materials management. The associate also maintains required training and may support less-experienced associates.

Requirements

High school diploma or GED with 4 years of related manufacturing experience; or an Associate degree with 2 years of related manufacturing experience; or a Bachelor’s degree with 0 years of related experience; or equivalent military training or experience.
Knowledge of cGMP, safety, and manufacturing procedures.
Experience operating equipment within a manufacturing unit operation.
Ability to understand manufacturing cadence and the order of shift activities.
Ability to assist with troubleshooting and document work accurately.
Strong teamwork, communication, and adaptability.
Flexibility with working hours and shift rotations.
Ability to work at heights greater than 4 feet and in environments that may necessitate respiratory protection.
Ability to discern verbal cues and sit or stand for prolonged periods.
Ability to ascend or descend ladders, scaffolding, ramps, and similar structures.
Ability to move objects up to 33 pounds and perform repetitive tasks using wrists, hands, or fingers.
Ability to bend, push or pull, reach to retrieve materials from 18–60 inches in height, and use twisting motions.
Ability to work in mechanical or production spaces that may require hearing protection and enrollment in a hearing conservation program.

Responsibilities

Contribute to operational-readiness activities for biopharmaceutical manufacturing.
Support procedure creation, process transfer, equipment testing, commissioning, and validation activities.
Independently execute and document manufacturing processing and support activities according to SOPs and cGMP requirements.
Perform process monitoring and in-process testing, including pH, conductivity, and visual inspections.
Operate assigned production equipment and perform qualified unit operations.
Support basic troubleshooting and escalate operational concerns appropriately.
Assist with cycle counts and materials management within the assigned functional area.
Maintain all required training and qualifications.
Support and guide less-experienced associates when appropriate.
Perform other duties as assigned.