**Overview** **Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO** The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki. **Join us** We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. **External US** **About This Role** This role will lead and execute manufacturing processing steps and associated activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. While in project phase, the schedule will be Monday-Friday during normal business hours. Upon transitioning to operations, this position will transition to a day or night shift that will be defined prior to the transition. **What You’ll Do** _During Project Phase:_ + Contribute 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:_ + Lead, execute and document manufacturing processing steps and/or manufacturing support activities: Process monitoring and control + Perform in-process testing (pH, conductivity, visual inspection) + Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) + Maintain training to perform all required manufacturing activities + Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area + This role requires shift work (weekend and potential for nights) + Perform other duties as assigned **Who You Are** You have the ability to assist in troubleshooting. You have strong verbal and written communication skills. You have knowledge of the operation of production equipment in their respective unit operation. You have a basic understanding of manufacturing run cadence and order of shift activities. You are knowledgeable in cGMP, safety and operational procedures. You have the ability to work in a team environment. **Basic Requirements** + High School Diploma or GED + 4 years of related experience in a manufacturing environment **Preferred Requirements** + Associate’s Degree OR + BA/BS, preferably in Life Sciences or Engineering + Associate’s Degree + 2 years of related experience in a cGMP manufacturing environment OR + Equivalent Military training or experience + Qualified experience on unit operation (DPFG Filler or Cell Culture – Seed Train) + BioWorks or BTEC Capstone cGMP coursework preferred **WORKING CONDITIONS & 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 + Experience 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 _FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email_ FDBN_PNC@fujifilm.com _._ _To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._ **Job Locations** _US-NC-Holly Springs_ **Posted Date** _3 weeks ago_ _(11/22/2024 7:49 AM)_ **_Requisition ID_** _2024-32439_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_