**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 the Role:** This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Aura project, a greenfield construction project in Holly Springs, NC. The initial assignment is to assume the Responsible Engineer role for **Chromatography** and **Column Packing** unit operations. As the site moves into commercial operations circa 2027, this position is planned to continue as primary support for **Chromatography** and **Column Packing** unit operations, with secondary responsibility expanding to cover additional Downstream unit operations includes supporting commercial operations, technology transfers, and small capital projects. Additional details regarding job responsibilities are below. **Major Accountabilities:** • Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider • Secures on time delivery and ensures quality from Fujifilm EPCM provider for equipment packages with limited complexity • Develops and aligns basic plans and provides mitigations, as needed • Reviews piping and instrumentation diagrams (P&IDs) and other process design documents • Provides direction to detailed design activities in partnership with the EPCM provider • Writes User Requirements Specifications (URSs) • Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities • Serves as on-call support for process equipment • Reviews, redlines, and approves P&IDs and other technical documents with limited supervision • Performs system impact assessments and quality risk assessments for process equipment • Performs technology transfer (TT) activities related to process equipment • Supports execution of Good Manufacturing Practices (GMP) runs • Provides technical support for root cause analysis (RCA) and process deviation investigations • Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures • Makes decisions regarding technical risk assessments for new manufacturing equipment • Provides on-floor manufacturing support for equipment issues • Provides process equipment training and consultation on topics within assigned area • Supports continuous improvement projects in partnership with Maintenance and Manufacturing • Cross-trains on multiple unit operations to assist team with achieving deliverables • Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation • Other duties, as assigned **Basic Requirements:** • Bachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 2 years of Engineering experience; or • Master’s degree in Chemical or Biotechnology Engineering with no prior experience • Experience in a Life Science or other regulated industry • Experience with Engineering drawings and using Quality Systems (e.g., deviation management, change control, CAPA, document management system) **Preferred Requirements:** • Prior experience working in a cGMP environment or other highly regulated industry • Experience working in at least one unit operation in a pharmaceutical or Life Science environment • Prior experience with mammalian cell culture processes Ability to ascend or descend ladders, scaffolding, ramps, etc. May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. _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** _4 weeks ago_ _(11/20/2024 8:47 AM)_ **_Requisition ID_** _2024-32552_ **_Category_** _Engineering_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_