Biopharma Manufacturing Associate 3: Upstream/Downstream

NCBioImpact; Holly Springs (NC); On-site; USD 45,000 - 65,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is hiring a Manufacturing Associate 3 to support biopharmaceutical production in a 24/7 cGMP environment. The role focuses on execution, documentation, process monitoring, and adherence to SOPs.

Flexibility with shift rotations is required. Minimum qualifications include a high school diploma with multiple years of manufacturing experience or an equivalent degree, plus knowledge of cGMP and equipment operation.

Qualifications

• High school diploma or GED with 4 years of related manufacturing experience or an Associate/Bachelor’s degree with related manufacturing experience.
• Knowledge of cGMP, safety, and manufacturing procedures.
• Experience operating equipment within a manufacturing unit operation.
• Ability to understand manufacturing cadence and shift activities.
• Ability to troubleshoot and document work accurately.
• Strong teamwork, communication, and adaptability.

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 elevate 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.

Skills

cGMP knowledge

Safety procedures

Manufacturing procedures

Equipment operation

Troubleshooting

Teamwork

Communication

Adaptability

Education

High school diploma or GED

Associate degree

Bachelor’s degree

Equivalent military training or experience

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is hiring a Manufacturing Associate 3 to support biopharmaceutical production in a 24/7 cGMP environment. The role focuses on execution, documentation, process monitoring, and adherence to SOPs.

Flexibility with shift rotations is required. Minimum qualifications include a high school diploma with multiple years of manufacturing experience or an equivalent degree, plus knowledge of cGMP and equipment operation.