Manufacturing Specialist , Materials

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.

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we will open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We are looking for mission-driven people to help realize this vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and cultivate a culture that fuels purpose, energy, and drive.

Holly Springs combines small-town warmth with proximity to Raleigh’s tech scene. Fujifilm is headquartered in Tokyo with over 70,000 employees across healthcare, electronics, business innovation, and imaging. Our Group Purpose is "giving our world more smiles".

Why this role matters

You will blend hands-on support with documentation, planning, and problem-solving to keep production running smoothly and safely. Your work will 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, act 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:
  Bio Works 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.

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 contact our HR Department ().