Manufacturing Specialist 1, Materials

Help build and sustain reliable, compliant manufacturing at a world-class, 24/7 biomanufacturing site in Holly Springs, North Carolina. Fujifilm Biotechnologies is constructing North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, integrating drug substance production, fill-finish, and packaging under one roof by the end of 2025.

About the role

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.

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

Responsibilities

• Support operational readiness initiatives as well as site commissioning and qualification efforts during the project phase.
• Act as a process subject matter expert for assigned area(s), supporting troubleshooting in operations.
• 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.

Requirements

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.

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.
• Preferred: BioWorks or BTEC Capstone cGMP coursework.

Skills

• 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.

Schedule

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