Manufacturing Specialist 2, DP

Fujifilm•Holly Springs, NC

About The Position

This role as Manufacturing Specialist 2 will performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. 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 Job Description What You’ll Do

Requirements

High school Diploma or GED with 12 years of related experience
Strong manufacturing operations experience
High degree of understanding of operations sequence and cadence of activities

Nice To Haves

Associate degree and 10 years of direct experience OR
BA/BS and 8 years of direct exp OR
Equivalent Military experience
Bio Works or BTEC Capstone cGMP coursework preferred

Responsibilities

During the project phase, support operational readiness initiatives as well as site commissioning and qualification efforts.
Support trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s).
Coordinate Batch Planning including process template creation and import and management of PMs.
Own, perform, or drive documentation major documentation updates (Initiate new documents for new processes)
Coordination of non-batch activities including but not limited to Changeover, PMs, column packing, APS.
Support tech transfer within manufacturing domain.
Ensure compliance and safety procedures are followed in manufacturing environment.
Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities.
Lead large scale improvement projects in DPFG
Assist and support inspections and audits, providing support to ensure compliance within the manufacturing environment.
Assist in creating work schedules for junior staff.
Perform other duties as assigned.