Manufacturing Associate 3, Filling

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. Our dynamic work environment cultivates a culture that fuels purpose, energy, and drive—what we call Genki. Holly Springs combines small-town warmth with proximity to Raleigh’s thriving tech scene, offering the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across healthcare, electronics, business innovation, and imaging segments. We are guided by our Group Purpose of “giving our world more smiles.”

About the Role

As a Manufacturing Associate 3 in Drug Product, you’ll play a hands-on role in component/parts preparation, thawing and formulation, sterile filling, and visual inspection—supporting a 24/7 operation that keeps patients at the center. You’ll help shape processes, train new colleagues, and support equipment qualification and startup activities for our DPFG facility. Our environment values clear communication, teamwork, and continuous improvement, allowing you to contribute, learn, and grow.

Responsibilities

• Lead, execute, and document manufacturing processing steps and/or support activities, including process monitoring and control
• Perform in-process testing (e.g., pH, conductivity, visual inspection) with accuracy and attention to detail
• Execute validation protocols in alignment with cGMP Standard Operating Procedures (SOPs)
• Maintain training qualifications to perform all required manufacturing activities
• Perform operations across Drug Product unit operations, including:
  • Parts Washer and Autoclave
  • Compounding/Formulation
  • Sterile Filling (including isolator technology)
  • Manual and/or Automated Visual Inspection
• Assist and/or lead cycle counts; manage materials for assigned manufacturing areas
• Assist the lead with daily manufacturing tasks and coordinate daily shift activities as needed
• Support projects that improve Drug Product manufacturing processes, including training of new colleagues
• Maintain compliance of cGMP documents and assist in equipment qualification and DPFG facility startup activities
• Follow safe work practices and escalate issues promptly to maintain product quality and compliance

This role may require shift work (weekends and potential nights) and other duties as assigned.

Requirements

Minimum Qualifications (one of the following is required):

• 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 Life Sciences or Engineering); OR
• Equivalent military training or experience

Qualifications

Preferred Qualifications:

• Qualified experience on unit operations such as Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection
• BioWorks or BTEC Capstone cGMP coursework

What Helps You Succeed:

• Ability to assist in troubleshooting and apply sound judgment on assignments
• Strong verbal and written communication skills
• Knowledge of production equipment operations within your unit operation(s)
• Basic understanding of manufacturing run cadence and order of shift activities
• Knowledge of cGMP, safety, and operational procedures
• Ability to work effectively in a team environment
• Flexibility for shift rotation and weekend/night work in a 24/7 facility

Work Environment & Physical Requirements

• May require respiratory and hearing protection; ability to discern audible cues and perform tasks requiring 20/20 corrected vision (including color)
• Ability to ascend/descend ladders; perform repetitive motions with wrists/hands/fingers
• Ability to operate machinery/power tools and, as required, motor vehicles or Powered Industrial Trucks
• Ability to lift/move up to 33 lbs; bend, push/pull, and reach between 18" and 60" in height
• Comfortable working at heights greater than 4 feet
• Prolonged standing and sitting may be required depending on shift activities

Benefits

• Competitive pay with shift differentials where applicable
• Comprehensive health coverage (medical, dental, vision)
• Paid time off, holidays, and sick leave
• Retirement savings plan with company contribution
• Training and development opportunities, including cGMP upskilling and mentorship
• Inclusive, team-centered culture focused on safety, quality, and continuous improvement
• Employee assistance and well-being resources
• Opportunities to contribute to startup and optimization initiatives in a modern DP facility