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 Tech 3, Instrumentation & Controls (I&C) is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and know-how.

What You’ll Do

• Performs calibrations to instrumentation and controls, and site equipment and systems
• Plans and manages I&C / Calibration and repair activities for the entire site
• Performs routine I&C maintenance and repair of site equipment and machinery
• Participates in developing and implementing strategies to improve equipment reliability and reduce downtime
• Trains and mentors’ technicians
• Maintains accurate I&C / Calibration maintenance records and documentation
• Evaluates and recommends new equipment purchases and upgrades
• Participates in developing and maintaining maintenance budgets and schedules
• Assists management with budget forecast for maintenance and capital projects
• Follows standard procedures and protocols to ensure compliance with safety and Good Manufacturing Practices (cGMP) quality standards
• Provides input and recommendations for written instructions of preventive maintenance tasks and standard operating procedures (SOPs)
• Adheres to all safety requirements and follow safe work practices
• Notifies management or Environmental Health & Safety (EHS) when unsafe conditions or hazards are found
• Attends all required and safety and health training
• Supports site operations and emergency work orders during off-hours, as needed
• Performs spare parts assessments, as required
• Other duties, as assigned

Knowledge & Skills

• Proficient knowledge of mechanical, electrical, and control systems
• Effective communication, both written and oral
• Ability to work in a team environment
• Knowledge of lean manufacturing principles
• Must be able to work shifts and on-call, as neede

Required Skills

• High School Diploma/GED
• 6 years of I&C experience or similar field
• Experience in a GMP or another regulated environment

Preferred Skills

• Associates degree in Mechanical, Electrical, or Chemical Engineering or a related field
• 7+ years of maintenance experience in a pharmaceutical or similar manufacturing environment
• Experience mentoring or providing oversight to technicians in a pharmaceutical or similar manufacturing setting
• Experience with Computerized Maintenance Management Systems (CMMS), such as ProCalV5, Blue Mountain, Maximo, Infor EAM, etc.

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. No X Yes May be required to operate a pallet jack
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 60 minutes
Ability to sit for prolonged periods of time. No X Yes 60 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., more with assistance
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.