**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. **Check out the FDB Holly Springs Site! (https://www.streamio.com/api/v1/videos/64df84ca6f8d8df16d000001/public\_show?player\_id=5d136e976f8d8d57e6000009&link=true)** **External US** **About This Role** The role as Manufacturing Associate 4 will execute manufacturing processing steps and associated activities. 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. 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 + Support and/or assist senior level associates or supervisor with scheduling daily activities on manufacturing floor, as needed    + This role requires shift work (weekend and potential for nights) + Perform other duties as assigned **Who You Are** You have an advanced understanding of Manufacturing run cadence and order of shift activities. You are knowledgeable in cGMP, safety and operational procedures. You have strong troubleshooting ability. You have strong verbal and written communication skills. You have the ability to adapt in a fast-paced changing environment, pivot and are willing to adjust plans accordingly. You have strong time management skills. You have the ability to think critically and have superior problem-solving skills. You have a team-based attitude and ability to work in a global team environment, build relationships and communication effectively with others. **Basic Requirements** + High School Diploma or GED + 6 years of experience in life science's manufacturing **Preferred Requirements** + BA/BS, preferably in Life Sciences or Engineering + 2 years of experience in life sciences manufacturing OR + Associate’s degree + 4 years of experience in life sciences manufacturing OR + Equivalent Military Training/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 + BioWorks or BTEC Capstone – cGMP coursework preferred **PHYSICAL REQUIREMENTS** **_PHYSICAL DEMANDS_** + Will work in environment which may necessitate respiratory protection + May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. + Ability to discern audible cues **WORKING ENVIRONMENT** **_PHYSICAL DEMANDS_** + Ability to ascend or descend ladders, scaffolding, ramps, etc. + Ability to stand for prolonged periods of time. + Ability to sit for prolonged periods of time. + Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers. + Ability to conduct work that includes moving objects up to 33 lbs. + Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. **_ENVIRONMENTAL CONDITIONS_** + Will work in heights greater than 4 feet _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_ _(11/26/2024 10:26 AM)_ **_Requisition ID_** _2024-32674_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_