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.

About This Role

The Associate Manager, Maintenance ensures the efficiency and operational reliability of the process equipment and systems through effective preventive and corrective maintenance practices. This role sets the direction and manages the development of the process maintenance teams as the site transitions from construction to operations. Additionally, this role helps establish an efficient program design fit for future operations by utilizing current Good Manufacturing Practice (cGMP)/Good Laboratory Practice (GLP) knowledge, work scheduling, and equipment repair and troubleshooting. The Associate Manager, Maintenance also provides day‐to‐day oversight and development of the process maintenance team.  

What You’ll Do 

• Executes a maintenance strategy to ensure the safe and reliable operation of the site’s equipment and systems
• Leads a team of maintenance technicians through troubleshooting and repairing equipment failures, conducting preventative maintenance, and performing equipment modifications and upgrades
• Develops and maintains maintenance procedures, work instructions, and standard operating procedures (SOPs)
• Designs and implements reliability driven maintenance and monitoring plans and practices
• Oversees 3rd party service providers and ensures adherence to maintenance standards and procedures
• Adheres to and enforces compliance with all Quality, and Environmental, Health & Safety (EHS) and other applicable regulatory requirements (e.g.,
• Food & Drug Administration (FDA), Occupational Safety and Health Administration (OSHA) regulations, and cGMP)
• Identifies opportunities for process or system improvements and leads the respective implementation strategies
• Ensures all maintenance activities are completed in a cost‐effective manner
• Collaborates with other departments (e.g., Utility Operations, Spare Parts, Manufacturing, Quality Control, Engineering) to ensure maintenance activities support the overall goals of the site
• Supports the design, installation, commissioning, qualification, and training activities for maintenance
• Participates in site visits to FDB global locations for knowledge sharing and learning of best practices
• Coaches and mentors’ direct reports to foster professional development and growth
• Participates int eh recruitment process and retention strategies to attract and retain talent
• Addresses employee concerns and partners with HR, as needed for resolution
• Evaluates direct reports performance and address gaps accordingly
• Other duties, as assigned

Who You Are

You will manage the development of the process maintenance teams as the site transitions from construction to operations. Provide day‐to‐day oversight and development of the process maintenance team.  

Basic Requirements 

• Bachelor’s degree in Engineering or a related field with 8 years of maintenance and reliability experience in a pharmaceutical or other highly regulated industry OR
• Associate degree in Engineering or a related field with 10 years of maintenance and reliability experience in a pharmaceutical or otherhighly regulated industry OR
• High School Diploma/GED with 12 years of maintenance and reliability experience in a pharmaceutical or other highly regulated industry
• Experience working in a cGMP environment
• Prior experience managing a team of maintenance technicians
• Knowledge of technical documents (e.g., User Requirement Specification (URS), Site Acceptance Test (SAT), Factory Acceptance Test (FAT),
• Commissioning and Validation protocols)
• Strong knowledge of computerized maintenance management system (CMMS), such as Infor
• Ability to interpret cGMP regulations and their application to maintenance activities
• Effective communication, both written and oral
• Strong analytical and problem‐solving skills
• Ability to work in a fast‐paced environment
• Ability to lead a team and manage multiple projects simultaneously
• Knowledge of Microsoft Office (e.g., Word, Excel, Outlook, PowerPoint)
• Ability to present complex information to others
• Active passport
• Travel required, 10%

 Preferred Requirements 

• Experience with project management methodologies
• Experience with lean manufacturing principles
• Lead Six Sigma or other process improvement certifications
• Ability to ascend or descend ladders, scaffolding, ramps, etc.              No  X Yes
• Ability to stand for prolonged periods of time.              No  X Yes  240 minutes  
• Ability to sit for prolonged periods of time.              No  X Yes  240 minutes  
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.            No  X Yes
• Ability to operate machinery and/or power tools.             No  X 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.  X No             Yes
• Will work in warm/cold environments.  X No             Yes             Range (If yes, specify approximate temperature ranges.)
• Will work in outdoor elements such as precipitation and wind.            No  X Yes
• Will work in small and/or enclosed spaces.  X No             Yes
• Will work in heights greater than 4 feet.             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.