Manufacturing Associate 3, Visual Inspection (First Shift)

Position Overview

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.

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 mission-driven biopharmaceutical manufacturer dedicated to reliably supplying high-quality therapies. Our culture is inclusive, safety-focused, and rooted in collaboration and learning. We invest in our people, value diverse perspectives, and empower team members to grow their careers while making meaningful impact for patients.

 

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, or manual/automated visual inspection.

 

Qualifications — 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 correct