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 Engineer 2, I&C provides engineering support to field personnel in the performance of maintenance and operational tasks associated with instrumentation and automation systems and controls across the campus.  This role provides support for the metrology department through evaluations of instrument deficiencies, test equipment issues and calibration strategies and methods. This role supports deviation investigations and works directly with other Utility Engineers to ensure applicable safety and regulatory standards are maintained, identify process improvements, and assist with troubleshooting equipment issues to maintain overall plant reliability.

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
  
• Assists in the development of Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline
  
• Assists with deviations and change controls resolutions and closures, as needed
  
• Coordinates 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 standard engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.)
  
• Partners with Senior Engineers to review and approve Preventative Maintenance templates for equipment within assigned discipline
  
• Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues
  
• Supports the development of User Requirement Specs, Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting
  
• Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers
  
• Performs standard troubleshooting for equipment challenges
  
• Cross-trains on multiple disciplines to assist team with achieving deliverables
  
• Collaborates with other departments (e.g., Utility Operations, Facilities, Environmental Health & 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 2 years of experience with process utility related components and systems
  
• Experience working in a Good Manufacturing Practices (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, 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.