Manufacturing Associate 4, Drug Product Filling (1st Shift)

About the role

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team.

Responsibilities

• Participate and support testing activities, such as FAT, PQ etc. as well as other related activities
• Contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions
• Contribute to the preparation for operational readiness related to bulk drug product manufacturing
• Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support
• Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Own the establishment of processes and trainings to become a trainer for coworkers
• Maintain compliance of GMP documents and ensure own training level is compliant and maintained
• Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed
• Perform operations of the Drug product filling line
• Perform shift work (weekend and potential for nights)
• Perform other duties as assigned

Requirements

• High School Diploma or GED
• 6+ years of direct experience in a manufacturing environment
• Associate’s Degree + 4 years of direct experience in a cGMP manufacturing environment OR BA/BS + 2 years of direct experience in a cGMP manufacturing environment
• Equivalent Military training or experience
• Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing)
• Understanding of manufacturing run cadence and order of shift activities
• Knowledge of cGMP, safety and operational procedures
• A high degree of knowledge and expertise of the operation of specific production equipment

Physical Requirements

• Be exposed to an environment that may necessitate respiratory protection
• Be exposed to noisy environments
• Have a normal range of vision
• Climb ladders and stairs of various heights
• Experienced prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours
• Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required
• May be required to lift up to 50 pounds on occasion

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!