Manufacturing Associate 3, Filling (Second Shift 3pm to 11:30pm)

About the role

Do you thrive in a fast-paced, highly regulated environment where precision, teamwork, and continuous improvement make a real difference for patients? Join our Drug Product team as a Manufacturing Associate III to lead hands-on operations across formulation, sterile filling, and visual inspection—while helping stand up and optimize a state-of-the-art DP facility.

About us

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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.

Responsibilities

• Lead, execute, and document manufacturing processing steps and manufacturing support activities, including process monitoring and control.
• Perform in-process testing, including pH, conductivity, and visual inspection.
• Execute validation protocols in accordance with cGMP Standard Operating Procedures (SOPs).
• Maintain current training to perform all assigned manufacturing activities.
• Assist and/or lead cycle counts; manage materials for the assigned manufacturing functional area.
• Perform operations across Drug Product areas, such as:
  • Parts washing and preparation.
  • Autoclave operation.
  • Thawing and compounding/formulation of drug substance.
  • Sterile filling (including isolator technology).
  • Manual and/or automated visual inspection.
• Support projects that improve Drug Product manufacturing processes, including:
  • Training of new colleagues.
  • Maintaining cGMP documentation.
  • Assisting in equipment qualification and all aspects of DPFG facility startup.
• Assist the lead with manufacturing tasks and help coordinate daily shift activities to ensure smooth, safe operations.
• Work a shift schedule to support a 24/7 operation (weekends and potential nights may be required).
• Perform other duties as assigned.

Qualifications

• Minimum: High school diploma or GED with 4+ years of direct experience in a cGMP manufacturing environment; or Associate’s degree with 2 years of 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 at least one unit operation, such as:
  • Parts washer.
  • Autoclave operation.
  • Compounding/formulation.
  • Filling with isolator technology.
  • Manual/automated visual inspection.

Preferred

• BioWorks or BTEC Capstone cGMP coursework.

Skills and traits for success

• Ability to assist in troubleshooting and recommend solutions.
• Strong verbal and written communication skills.
• Knowledge of production equipment in your assigned unit operation(s).
• Basic understanding of manufacturing run cadence and order of shift activities.
• Working knowledge of cGMP, safety, and operational procedures.
• Ability to work effectively in a team environment and exercise sound judgment and initiative.

Work environment and physical requirements

• May require respiratory protection; may work in mechanical/production spaces requiring hearing protection and enrollment in a hearing conservation program.
• May operate a motor vehicle or Powered Industrial Truck (PIT).
• Ability to discern audible cues and perform tasks with 20/20 corrected vision, including color differentiation.
• Ability to ascend/descend ladders, scaffolding, and ramps; work at heights greater than 4 feet.
• Ability to stand and sit for prolonged periods; perform repetitive motions with wrists, hands, and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to move objects up to 33 lbs; bend, push/pull, and reach from 18" to 60" with twisting motions.
• No routine work in outdoor elements, small/enclosed spaces, or extreme temperatures.

Benefits

• Inclusive, team-first culture with strong emphasis on safety, quality, and continuous improvement.
• Hands-on experience across key Drug Product unit operations in a modern GMP facility (formulation, filling with isolator technology, and visual inspection).
• Opportunities to mentor peers and support new-hire training as the site scales.
• Professional growth and learning support, including cGMP and technical training; recognition of relevant coursework (e.g., BioWorks, BTEC Capstone).
• Competitive compensation and comprehensive benefits package, with potential shift differentials for eligible schedules.
• The chance to directly impact the reliable delivery of high-quality medicines to patients.