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

About the role

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.
• Absorb 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.
• 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.

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.

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.

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 (FDBN_PNC@fujifilm.com).