Clean Utilities Engineer 3-Black Utilities Engineer 3

We are hiring 2 Utility Engineers33104-Engineer 3-Clean Utilities33103-Engineer 3, Black UtilitiesOverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe 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 GenkiJoin usWe 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 solutionsto 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 - Black Utilities Engineer 3The Black Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Black Utilities, including Chilled Water Systems, Steam Boilers, Cooling Towers, HVAC and Glycol Chiller and Compressed Air 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.Job Description - Clean Utilities Engineer 3The 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 DoCoordinates 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 standardsDevelops Project Change Controls (PCCs) to document specific changes to the design of systems within assigned disciplinePrepares deviations and change control resolutions and closuresPerforms reviews of submittals, installation, and testing of equipment within assigned discipline across all buildings on sitePerforms field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawingsProvides 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 disciplineCollaborates with Utility Operators and Maintenance Technicians to resolve operational issuesDevelops or provides supports in the development of User Requirement Specs (URSs), Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting proceduresProvides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior EngineersMaintains Good Manufacturing Practices (GMP) compliance aspects of validated systemsParticipates in audits with customer representatives and regulatory agencies, as neededPerforms simple to moderate troubleshooting for equipment challenges and supports Senior Engineers with complex troubleshootingCross-trains within multiple disciplines to assist team with achieving deliverablesCollaborates with other departments (e.g., Utility Operations, Maintenance, Facilities, Environmental Health, and Safety)Other duties, as assignedKnowledge and SkillsEffective communication, both written and verbalKnowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulationsProficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint)Ability to utilize software programs related to job responsibilitiesAbility to analyze and troubleshoot system and component related issuesAbility to effectively present information to othersBasic RequirementsBachelor's Degree in Engineering with 5 years of experience with process utility related components and systemsExperience working in a GMP or other highly regulated environmentPreferred RequirementsExperience establishing processes and procedures for operation, troubleshooting and monitoring process utility systemsTo 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.

Created: 2025-02-04