Manufacturing Specialist, Manufacturing Support

Position Overview Make an impact Help us run a world-class drug substance manufacturing operation that's safe, compliant, and always ready. As a Manufacturing Specialist, Manufacturing Support, you'll be the bridge between the manufacturing floor, quality, and engineering—keeping batches on plan, documents up to date, and the site audit-ready while driving continuous improvement. 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."

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https://www.fujifilm.com/us/en/about/region/careers Job Description What you'll do Project phase Support operational readiness activities, including site commissioning and qualification. Operations Serve as a process SME for assigned area(s); support troubleshooting to rapidly restore and sustain reliable operations.

Coordinate batch planning:

create process templates, import data, and manage preventive maintenance (PMs). Maintain accurate, current documentation with timely redlines and process improvements. Coordinate non‑batch activities such as changeovers, PMs, and column packing. Assist with inventory management and support effective SAP use across manufacturing. Support technology transfer within the manufacturing domain. Ensure adherence to safety and cGMP compliance across the manufacturing environment.

Manage/perform/support quality records:

change management, investigations, CAPAs, and continuous improvement (CI) activities. Identify and/or drive improvement projects within drug substance manufacturing. Assist and support inspections and audits to maintain a state of compliance. Perform other duties as assigned. Minimum education and experience Meet one of the following: High School Diploma/GED and 10 years of related experience; OR Associate's degree, preferably in life sciences or engineering, with 8 years of direct experience; OR Bachelor's degree, preferably in life sciences or engineering, with 6 years of direct experience; OR Equivalent military experience/training. Preferred qualifications Strong cGMP manufacturing operations experience. Understanding of operations sequence and cadence of activities. Prior experience updating and creating manufacturing documents per schedule. BioWorks or BTEC Capstone cGMP coursework preferred. What helps you thrive here Strong verbal and written communication. Excellent time management; comfortable pivoting in a fast‑paced environment. Critical thinking and superior problem‑solving skills. Team-first mindset; able to build relationships and communicate effectively across global, cross‑functional groups. Operates as a fully qualified, independent professional who can influence diverse stakeholders. Why you'll love it Meaningful, patient-focused work with clear impact. Growth, learning, and cross-functional collaboration in a modern biomanufacturing setting. Safety-first culture that embraces continuous improvement.

To all agencies:

Please, no phone calls or emails to any employee of

FUJIFILM

about this requisition. All resumes submitted by search firms/employment agencies to any employee at

FUJIFILM

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FUJIFILM

for this requisition and a valid agreement with

FUJIFILM

is in place. In the event a candidate who was submitted outside of the

FUJIFILM

agency engagement process is hired, no fee or payment of any kind will be paid. •#LI-Onsite EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).