Manufacturing Associate , Drug Product Filling; 1st Shift

Manufacturing Associate 3, Drug Product Filling (1st Shift)

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and assists in qualification of equipment and all aspects of startup of the DPFG facility.

The manufacturing facility will be 24/7 operational and the role 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’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.”

• 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.
• Perform operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection).
• Assist the lead with tasks in manufacturing activities.
• Assist with the coordination of daily shift activities.
• This role may require shift work (weekend and potential for nights).
• Perform other duties as assigned.

• High School Diploma or GED with 4+ years of direct experience in a cGMP manufacturing environment.
• Associate’s Degree + 2 years direct experience in a cGMP manufacturing environment, or
• Bachelor’s Degree, preferably in Life Sciences or Engineering, or
• Equivalent Military training or experience.

• Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection).
• Bio Works or BTEC Capstone cGMP coursework preferred.

• Be exposed to an environment that may necessitate respiratory protection.
• May work in mechanical/production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Will work in environment operating a motor vehicle or powered industrial truck.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time.
• Ability to sit for prolonged periods of time.
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in heights greater than 4 feet.

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 ().

• Entry level

• Full‑time

• Research, Analyst, and Information Technology