Manufacturing Specialist 1, Training

Fujifilm•Holly Springs, NC

2d•Onsite

About The Position

Ignite operational excellence in a 24/7 manufacturing environment. As a Manufacturing Specialist I, Training, you will strengthen compliant, reliable production by building capability on the floor, coordinating critical operations, and serving as a go-to subject matter expert. If you are passionate about hands-on manufacturing, teaching others, and driving continuous improvement, this role is for you. This facility operates around the clock; flexibility with working hours and shift rotation is required. This position will support both day and night shift trainings. 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.”

Requirements

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
Strong verbal and written communication skills
Strong time management and the ability to prioritize and meet deadlines
Adaptability in a fast‑paced environment; able to pivot and adjust plans quickly
Critical thinking and superior problem‑solving skills
Team‑based mindset; ability to build relationships and work effectively in a global team environment
Pharmaceutical industry experience
Aseptic qualifications training
Experience creating training materials and facilitating trainings; ability to support both day and night shift trainings

Nice To Haves

Strong current Good Manufacturing Practice manufacturing operations experience
Understanding of the sequence of operations and cadence of activities
Prior experience updating and creating manufacturing documents on schedule
BioWorks or BTEC Capstone current Good Manufacturing Practice coursework preferred

Responsibilities

Support operational readiness initiatives that prepare people, processes, and systems for start‑up.
Support site commissioning and qualification efforts to ensure equipment and facilities are ready for compliant use.
Support troubleshooting in assigned process areas, acting as a process subject matter expert to resolve issues and minimize downtime.
Coordinate batch planning, including creating process templates and importing/managing preventive maintenance activities.
Maintain accurate, up‑to‑date documentation; complete timely updates of records, including redlines and process improvements.
Coordinate non‑batch activities such as changeovers, preventive maintenance, and column packing.
Assist with inventory management and support the use of the enterprise resource planning system (SAP) for efficient manufacturing operations.
Support technology transfer activities within manufacturing.
Ensure adherence to safety and compliance procedures across 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 to enhance throughput, reliability, and quality.
Assist and support inspections and audits by providing complete and accurate documentation; help ensure ongoing compliance across operations.
Perform other duties as assigned to meet production, quality, and safety goals.
Create engaging, compliant training content for manufacturing processes, documentation practices, and safety procedures.
Facilitate effective training sessions and certifications across day and night shifts, including onboarding and upskilling for new processes and improvements.
Leverage aseptic qualifications training and pharmaceutical best practices to elevate operational performance.