Manufacturing Specialist 1, Materials

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

Overview

Help build and sustain reliable, compliant manufacturing at a world‑class, 24/7 biomanufacturing site. As a Manufacturing Specialist I, Materials, you will be a key driver of operational readiness, daily production excellence, and continuous improvement. This role supports a round‑the‑clock operation and may require flexibility with working hours and shift rotation.

External US

 

Why this role matters

You will blend hands‑on support with strong documentation, planning, and problem‑solving to keep production running smoothly and safely. Your work will directly impact product quality, schedule adherence, and the success of technology transfers and inspections.

 

What you’ll do

 

During project phase:

• Support operational readiness initiatives as well as site commissioning and qualification efforts.

 

In operations:

• Support troubleshooting, acting as a process subject matter expert for assigned area(s).
• Coordinate batch planning, including process template creation, import, and management of preventive maintenance activities.
• Maintain accurate, current documentation; drive timely updates to records and implement redlines and process improvements.
• Coordinate non‑batch activities, including changeovers, preventive maintenance, and column packing.
• Assist with inventory management and support use of enterprise systems (e.g., SAP) for effective manufacturing operations.
• Support technology transfer within the manufacturing domain.
• Ensure compliance with procedures and safety requirements in the manufacturing environment.
• Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions, and continuous improvement activities.
• Identify and drive improvement projects in drug substance manufacturing.
• Assist and support internal and external inspections and audits to maintain compliance.
• Perform other duties as assigned to meet production and quality objectives.

 

Work schedule

• 24/7 operational facility; flexibility with working hours and shift rotation is required.

 

Minimum education and experience

• 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 current Good Manufacturing Practice (cGMP) manufacturing operations experience.
• Solid understanding of operations sequence and cadence of activities.
• Prior experience updating and creating manufacturing documents according to schedule.

Training and certifications

• Preferred: BioWorks or BTEC Capstone cGMP coursework.

 

What helps you succeed here

• Strong verbal and written communication skills.
• Excellent time management and the ability to prioritize in a fast‑paced environment.
• Adaptability—able to pivot and adjust plans as priorities shift.
• Critical thinking and superior problem‑solving skills.
• A team‑first mindset with the ability to work effectively in a global, cross‑functional environment and build strong relationships.

 

Ready to make an impact in a high‑growth, high‑standards manufacturing environment? Apply today and help us deliver life‑changing medicines with quality and speed.

 

To all agencies: Pleas