Manufacturing Associate – Downstream; Day Shift

Position Overview

This role will lead and execute manufacturing processing steps and associated activities. 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."

• Contribute to the preparation for operational readiness related to bulk drug substance manufacturing
• Possible assignments include:
  Supporting projects related to – Procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
• Travel up to 0-25% (international or domestic) may be required

• Lead, execute and document manufacturing processing steps and/or manufacturing support activities:
  Process monitoring and control
• Perform in-process testing (pH, conductivity, visual inspection)
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Maintain training to perform all required manufacturing activities
• Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area
• This role requires shift work (weekend and potential for nights)
• Perform other duties as assigned

You have the ability to assist in troubleshooting. You have strong verbal and written communication skills. You have knowledge of the operation of production equipment in their respective unit operation. You have a basic understanding of manufacturing run cadence and order of shift activities. You are knowledgeable in cGMP, safety and operational procedures. You have the ability to work in a team environment.

• High School Diploma or GED
• 4 years of related experience in a manufacturing environment

• Associate’s Degree OR
• BA/BS, preferably in Life Sciences or Engineering
• Associate’s Degree + 2 years of related experience in a cGMP manufacturing environment OR
• Equivalent Military training or experience
• Qualified experience on unit operation (DPFG Filler or Cell Culture — Seed Train)
• Bio Works or BTEC Capstone cGMP coursework preferred

• Be exposed to an environment that may necessitate respiratory protection
• Be exposed to noisy environments
• Have a normal range of vision
• Climb ladders and stairs of various heights
• Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours
• Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required
• May be required to lift up to 50 pounds on occasion

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.

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 ().