Manufacturing Associate 3, Upstream/Downstream
About The Position
The Manufacturing Associate 3 supports the execution and documentation of manufacturing processing activities in a cGMP environment. The role contributes to project-phase readiness and steady-state operations in a 24/7 facility, helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required. The position includes contributing to operational-readiness activities; supporting procedure creation, process transfer, equipment testing, commissioning, and validation; and independently executing and documenting manufacturing processing and support activities according to SOPs and cGMP requirements. The associate also performs process monitoring and in-process tests, operates assigned equipment and qualified unit operations, assists with troubleshooting and materials management, maintains required qualifications, and may guide less-experienced associates. The role is onsite in Holly Springs, North Carolina. The physical environment may include working at heights greater than four feet, respiratory protection, hearing protection, prolonged sitting or standing, ladder or scaffold use, repetitive tasks, and moving objects up to 33 pounds.
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; sit or stand for prolonged periods; ascend or descend ladders, scaffolding, and ramps; move objects up to 33 pounds; perform repetitive tasks using wrists, hands, or fingers; and bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and twist.
- May work in mechanical or production spaces requiring 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
