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 Senior Reliability Engineer is responsible for life cycle asset management. This role monitors equipment performance and identifies and mitigates issues related to system and equipment reliability. Additionally, this role works with the Plant Engineering team to develop maintenance strategies to optimize equipment performance. This role functions as a maintenance lead in root cause analysis, analyzing equipment failures, and creating predictive forecasts for system optimization.

What You’ll Do

• Analyzes data of corrective work orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics (QEM) to identify trends and areas of improvements
• Assesses risk and reliability of assets associated with manufacturing and support systems including but not limited to failure mode analysis, mean time to failure (MTTF), and mean time to repair (MTTR)
• Develops and maintains the Reliability Centered Maintenance (RCM) strategy to optimize maintenance programs within assigned area
• Participates in the development and implementation of other continuous improvement initiatives
• Establishes and maintains Key Performance Indicators (KPIs) for the overall health of the critical utility and process systems and builds tools to exercise and evaluate KPIs
• Implements measures to baseline maintenance performance and improvement targets as they relate to cost, quality, downtime, etc.
• Provides reliability, technical, and engineering services and guidance to optimize asset life and resolution to equipment design and operations
• Collaborates with other departments (e.g., Manufacturing, Maintenance, and Validation) to identify and solve problems while ensuring reliability is effectively integrated throughout the site
• Conducts training and presents information to team or other stakeholders, as needed
• Other duties, as assigned

Who You Are

You will monitor equipment performance and identifies and mitigates issues related to system and equipment reliability.

Basic Requirements

• Bachelor’s degree in Mechanical or Electrical Engineering, or another related field
• 8 years of Engineering and/or Maintenance experience
• Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, corrective and preventive action (CAPA), document management system)
• Effective communication, both written and oral
• Advanced problem-solving skills
• Ability to effectively present complex information to others
• Ability to provide feedback to others, including leaders
• Willingness to partner with global colleagues and lead sub teams
• Knowledge of Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), and Food & Drug Administration (FDA) regulations
• Knowledge of RCM and/or Total productive Maintenance (TPM)
• Knowledge of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA
• Knowledge of the operation and interdependencies of typical utility systems in a pharmaceutical plant (e.g., chillers and cooling towers), boilers/plant steam, utility piping & distribution systems, HVAC, electrical distribution systems, and pharmaceutical RODI, Clean Steam (CS), and
• Water for Injection (WFI) systems)

 Preferred Requirements

• Master’s degree in Mechanical or Electrical Engineering with 6+ years of Engineering or other relevant technical experience
• Prior experience working in a cGMP environment or other highly regulated industry
• Experience implementing KPIs and other reliability metrics
• Certified Maintenance and Reliability Professional
• Six Sigma

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No 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. X No 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. X No Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes

Ability to stand for prolonged periods of time. No X Yes, up to 120 minutes

Ability to sit for prolonged periods of time. No X Yes, up to 120 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. X No Yes

Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 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

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.