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 DescriptionAbout 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 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 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 assignedKnowledge and Skills
Effective communication, both written and verbalKnowledge 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 systemsExperience working in a GMP or other highly regulated environmentPreferred Requirements
Experience establishing processes and procedures for operation, troubleshooting and monitoring process utility systemsWORKING 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, 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.
Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Application FAQsSoftware Powered by iCIMS
www.icims.com