Manufacturing Associate 3 (Upstream)- Night Shift (2-2-3)
About The Position
Help us deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 3 to lead and execute manufacturing processing activities in a cGMP environment. You will support project-phase readiness (procedures, process transfer, testing/commissioning) and steady-state operations in a 24/7 facility—helping ensure safe, consistent, and efficient production of drug substance. This role requires flexibility with working hours and shift rotations. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers
Requirements
- High School Diploma or GED and 4+ years of related manufacturing experience; or
- Associate’s degree and 2+ years of related experience in a cGMP manufacturing environment; or
- BA/BS, preferably in Life Sciences or Engineering; or
- Equivalent military training/experience.
- Qualified experience on a unit operation (e.g., DPFG Filler or Cell Culture—Seed Train).
- Knowledge of production equipment operation within assigned unit operations.
- Basic understanding of manufacturing run cadence and order of shift activities.
- Knowledge of cGMPs, safety, and operational procedures.
- Ability to assist in troubleshooting; strong verbal and written communication skills.
- Ability to work effectively in a team environment.
Nice To Haves
- BioWorks or BTEC Capstone cGMP coursework.
Responsibilities
- Contribute to project-phase operational readiness for bulk drug substance manufacturing.
- Support procedure review/creation and development or transfer of manufacturing business processes.
- Provide testing and commissioning support for equipment/systems; travel up to 0–25% (domestic or international) may be required during the project phase.
- Lead, execute, and document manufacturing processing steps and/or support activities; perform process monitoring and control per cGMP standards.
- Perform in-process testing (e.g., pH, conductivity, visual inspection).
- Execute validation protocols according to cGMP Standard Operating Procedures (SOPs).
- Maintain required training and qualifications for all assigned manufacturing activities.
- Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area.
- Work assigned shifts in a 24/7 operation, including weekends and potential nights.
- 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
