**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. ***NOTE: This posting represents 2 Openings*** **External US** **About This Role** This role will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours. **What You’ll Do** + During the project phase, you will lead operational readiness initiatives as well as site commissioning and qualification efforts + Lead troubleshooting for their respective process area + Recommend and perform documentation updates + Coordinate non-batch activities and creation of associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), column packing + Create change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to support manufacturing + Execute and drive general improvement projects within Drug substance manufacturing + Work with cross-functional groups to organize equipment startup and transfer into GMP manufacturing + Support Inspections and audits by providing requested manufacturing documents  + Other duties as assigned  **Basic Requirements** + High School Diploma or GED and 6 years of related experience **OR** Associates degree with 4 years of direct experience **OR** + BA/BS with 2 years of direct experience + Equivalent Military training/experience **Preferred Requirements** + Associates or Bachelor’s in life sciences or engineering + BioWorks or BTEC Capstone cGMP coursework preferred **PHYSICAL REQUIREMENTS** **_PHYSICAL DEMANDS_** + Ability to discern audible cues **WORKING ENVIRONMENT** **_PHYSICAL DEMANDS_** + 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 10 lbs. **_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 8:34 AM)_ **_Requisition ID_** _2024-32672_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_