**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. **Job Description** **About This Role** The Clean Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies. **What You’ll Do** + Coordinates with Senior Utility Engineers within assigned discipline to ensure project deliverables (e.g., specification review, Factory Acceptance Tests (FATs) and visits, equipment installation, and issue resolution) are performed to the company standards + Develops Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline + Prepares deviations and change control resolutions and closures + Performs reviews of submittals, installation, and testing of equipment within assigned discipline across all buildings on site + Performs field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings + Provides engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.) + Reviews and approves Preventative Maintenance templates for equipment within assigned discipline + Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues + Develops or provides supports in the development of User Requirement Specs (URSs), Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting procedures + Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers + Maintains Good Manufacturing Practices (GMP) compliance aspects of validated systems + Participates in audits with customer representatives and regulatory agencies, as needed + Performs simple to moderate troubleshooting for equipment challenges and supports Senior Engineers with complex troubleshooting + Cross-trains within multiple disciplines to assist team with achieving deliverables + Collaborates with other departments (e.g., Utility Operations, Maintenance, Facilities, Environmental Health, and Safety) + Other duties, as assigned **Knowledge and Skills** + Effective communication, both written and verbal + Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations + Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint) + Ability to utilize software programs related to job responsibilities + Ability to analyze and troubleshoot system and component related issues + Ability to effectively present information to others **Basic Requirements** + Bachelor’s Degree in Engineering with 5 years of experience with process utility related components and systems + Experience working in a GMP or other highly regulated environment **Preferred Requirements** + Experience establishing processes and procedures for operation, troubleshooting and monitoring process utility systems **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** Will work in environment which may necessitate respiratory protection. No X Yes May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes Ability to discern audible cues. No X Yes Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes Ability to stand for prolonged periods of time. No X Yes 30 minutes Ability to sit for prolonged periods of time. No X Yes 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes Ability to operate machinery and/or power tools. X No Yes Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs. Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes _FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, s_ _ex, 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** _1 week ago_ _(1/15/2025 2:50 PM)_ **_Requisition ID_** _2025-33104_ **_Category_** _Engineering_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_