Manufacturing Associate 2 - Downstream (Day Shift)

Fujifilm•Holly Springs, NC

23h•Onsite

About The Position

Position Overview The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. 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 Major Accountabilities: During the project phase, Contributes to the preparation for operational readiness related to bulk drug substance manufacturing. Possible assignments include supporting projects related to, procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support Travel up to 0 ‐ 25% (international or domestic) may be required. In operations Executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control. Performs in ‐ process testing (pH, conductivity, visual inspection) Executes validation protocols according to cGMP Standard Operating Procedures (SOPs) Maintains training to perform all required activities. This role requires shift work (weekend and potential for nights). Performs other duties as assigned

Requirements

Knowledge of the operation of support process equipment
Understanding of cGMPs, safety and operational procedures
Ability to perform operations and document them accurately.
Ability to follow technical instructions and document them.
Ability to work closely and effectively in a team environment.
Strong verbal and written communication skills
Ability to adapt in a fast ‐ paced changing environment
High School Diploma or GED and 2 years of related experience

Nice To Haves

Associate degree, preferably in Life sciences or similar
2 years + direct experience in cGMP manufacturing environment
Internal or after training: Qualified on a support area (i.e. Formulation Buffer Prep, Media Prep or DSM Buffer prep)
BioWorks or BTEC Capstone cGMP coursework preferred.

Responsibilities

During the project phase, Contributes to the preparation for operational readiness related to bulk drug substance manufacturing.
Possible assignments include supporting projects related to, procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
Travel up to 0 ‐ 25% (international or domestic) may be required.
In operations Executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control.
Performs in ‐ process testing (pH, conductivity, visual inspection)
Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
Maintains training to perform all required activities.
This role requires shift work (weekend and potential for nights).
Performs other duties as assigned

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