Manufacturing Associate 3, Filling

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Manufacturing Associate 3, Drug Product to contribute to a 24/7 DPFG operation. The role focuses on preparing components, thawing and formulation, sterile filling, and visual inspection within a collaborative team.

Applicants should have a cGMP background and strong communication skills, with flexibility for weekend/night shifts and rotation. The team emphasizes safety, quality, and continuous improvement in a modern DP facility.

Qualifications

• cGMP manufacturing experience with high attention to detail.
• High school diploma or GED with 4+ years in a cGMP environment or an associate/bachelor degree with related experience.
• Bachelor’s in Life Sciences or Engineering preferred; military training acceptable.
• Experience with unit operations and equipment used in drug product manufacturing is a plus.

Responsibilities

• Lead and document manufacturing steps and process monitoring.
• Perform in-process testing (pH, conductivity, visual inspection) with accuracy.
• Execute validation protocols per cGMP SOPs.
• Maintain training qualifications for required manufacturing activities.
• Support Drug Product unit operations including sterilization, compounding, filling, and visual inspection.
• Assist with daily tasks and shift coordination; participate in improvement projects.

Skills

cGMP knowledge

Team communication

Shift flexibility

Education

High School Diploma or GED with 4+ years in cGMP

Associate’s Degree with 2 years in cGMP

Bachelor’s Degree in Life Sciences or Engineering

Equivalent military training or experience

Tools

Parts Washer

Autoclave Operation

Isolator Technology in Filling

Visual Inspection Equipment

Job description

Position Overview

Help deliver safe, high-quality medicines at scale. As a Manufacturing Associate 3, 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.

Company Overview

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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

About Us

• We are a collaborative Drug Product manufacturing team committed to operational excellence, safety, and cGMP compliance.
• 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—so you can contribute, learn, and grow.

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

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

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 escape issues promptly to maintain product quality and compliance
• This role may require shift work (weekends and potential nights) and other duties as assigned

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

Work environment and physical requirements (role‑specific)

• 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

EEO Information

Fujifilm is committedto 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.

ADA Information

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 ([e-mail]).