Manufacturing Support Associate , Training
Listed on 2026-09-22
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Manufacturing / Production
Production QC/QA, Regulatory Compliance Specialist, Lean Manufacturing / Six Sigma, Quality Engineering
Help power reliable, compliant, 24/7 biomanufacturing. As a Manufacturing Support Associate 3, Training (Downstream Manufacturing), you’ll be a hands‑on technical leader who drives operational readiness, leads troubleshooting, and champions training and documentation excellence—so teams can produce safely, consistently, and on time.
Company OverviewFUJIFILM 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:
Job Description- We are a dynamic, around‑the‑clock biomanufacturing site focused on delivering high‑quality products with safety and compliance at the core.
- You’ll join a collaborative team that values continuous improvement, knowledge‑sharing, and practical problem‑solving.
- We welcome people from all backgrounds and experiences and provide equitable opportunities for growth and impact.
- Lead operational readiness during project phases, including site commissioning and qualification efforts.
- Serve as a process subject matter expert (SME) for your area(s); lead troubleshooting to restore and sustain reliable operations.
- Coordinate batch planning, including building process templates, importing plans, and managing preventive maintenance (PM) schedules.
- Recommend and perform updates to manufacturing documentation to keep procedures current, clear, and compliant.
- Initiate and/or support training programs, onboarding, and curriculum development and management to build team capability.
- Coordinate non‑batch activities and documentation for changeover, PMs, and column packing.
- Support technology transfer activities to enable smooth scale‑up/scale‑down and process adoption.
- Initiate or support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) initiatives.
- Identify and/or drive highly technical improvement projects within Downstream Manufacturing (DSM) to enhance safety, quality, and efficiency.
- Support internal and external inspections and audits with accurate documentation and clear communication.
- Collaborate cross‑functionally; act independently to define methods and procedures on new assignments.
- Perform other duties as assigned to meet manufacturing goals in a 24/7 environment; flexibility with working hours may be required.
- High school diploma with 8 years of related experience OR
- Associate’s degree with 6 years of direct experience OR
- BS/BA with 4 years of direct experience
- Equivalent military experience or training
- Associate’s or Bachelor’s degree, preferably in life sciences or engineering
- Bio Works or BTEC Capstone cGMP coursework
- Expertise in manufacturing operations with a high degree of troubleshooting ability
- Strong technical experience with batch planning and creation of…
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