Manufacturing Associate 3, Visual Inspection (First Shift)

Fujifilm • Holly Springs, NC

7d • Onsite

About The Position

Join our Drug Product team as a Manufacturing Associate III to lead hands-on operations across formulation, sterile filling, and visual inspection. This role involves helping to stand up and optimize a state-of-the-art Drug Product facility in a fast-paced, highly regulated environment where precision, teamwork, and continuous improvement are crucial for patient outcomes. FUJIFILM Biotechnologies is establishing North America's largest end-to-end CDMO biopharmaceutical manufacturing facility in Holly Springs, North Carolina, offering drug substance production, fill-finish, and packaging. We are seeking passionate, mission-driven individuals to contribute to this vision and transform healthcare.

Requirements

• 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.
• 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.
• Ability to discern audible cues and perform tasks with 20/20 corrected vision, including color differentiation.
• 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.

Nice To Haves

• BioWorks or BTEC Capstone cGMP coursework.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED