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

Fujifilm•Holly Springs, NC

20h•Onsite

About The Position

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. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation. FUJIFILM Biotechnologies is building North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility in Holly Springs, North Carolina, set to open by the end of 2025. This facility will offer drug substance production, fill-finish, and packaging. The company seeks passionate, mission-driven individuals to help deliver vaccines, cures, or therapies, offering a dynamic work environment and a culture that fosters purpose, energy, and drive (Genki). Holly Springs combines small-town warmth with proximity to Raleigh’s thriving tech scene. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across healthcare, electronics, business innovation, and imaging, guided by the Group Purpose of “giving our world more smiles.”

Requirements

High School Diploma or GED
6+ years of direct experience in a manufacturing environment

Nice To Haves

Associate’s Degree + 4 years of direct experience in a cGMP manufacturing environment
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

Responsibilities

Participate and support testing activities, such as FAT, PQ etc. as well as other related activities during the project phase
Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions during the project phase
Contribute to the preparation for operational readiness related to bulk drug product manufacturing during the project phase
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 during the project phase
Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control in operations
Perform operations of the Drug product filling line in operations
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) in operations
Own the establishment of processes and trainings to become a trainer for coworkers in operations
Maintain compliance of GMP documents and ensure own training level is complaint and maintained in operations
Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed in operations
Perform other duties as assigned