Manufacturing Associate 3, Upstream/Downstream

Fujifilm•Holly Springs, NC

22h•Onsite

About The Position

The Manufacturing Associate 3 assists with the execution and documentation of manufacturing processing activities in a cGMP environment. The role supports project-phase readiness and steady-state operations in a 24/7 biopharmaceutical manufacturing facility, helping maintain safe, consistent, and efficient production. The position contributes to operational readiness, executes manufacturing activities according to SOPs and cGMP requirements, and may support and guide less-experienced associates. Flexibility with working hours and shift rotations is required.

Requirements

High school diploma or GED and 4 years of related manufacturing experience; or an Associate degree and 2 years of related manufacturing experience; or a Bachelor's degree and 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 discern verbal cues.
Ability to sit and stand for prolonged periods.
Ability to ascend or descend ladders, scaffolding, ramps, and similar structures.
Ability to move objects weighing up to 33 pounds.
Ability to perform repetitive tasks using wrists, hands, and/or fingers.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.

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.