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 Maintenance Tech is responsible for the installation, maintenance, and repair of process related systems/equipment. Ensure these systems meet the stringent requirements of pharmaceutical manufacturing. Also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime. While in project phase, the schedule will be M-F during normal business hours.  Upon transitioning to operations, this position will transition to the appropriate shift that will be defined prior to the transition.  

What You’ll Do 

• Performs preventative maintenance and repairs on process equipment, such as bioreactors, centrifuges, ultrafiltration skids, parts washers, autoclaves, isolators, and fillers
• Provides recommendations to develop preventative maintenance plans to minimize equipment downtime
• Contributes to Standard Operating Procedure (SOPs) development and revisions for process maintenance related activities
• Diagnoses and troubleshoots equipment malfunctions
• Assists in the installation and commissioning of new equipment
• Maintains accurate maintenance records and documentation
• Follows SOPs to ensure compliance with safety and Good Manufacturing Practices (GMP) quality standards
• Adheres to all safety requirements and follows safe work practices
• Notifies management or Environmental, Health & Safety (EHS) when unsafe conditions or hazards are found
• Attends all required 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

Who You Are

You have knowledge in mechanical, electrical, and control systems. You have knowledge of GMP requirements. You have effective communication skills, both written and oral. You have the ability to work in a team environment.

Basic Requirements 

• High School Diploma/GED
• 2 years of maintenance experience in a pharmaceutical or similar manufacturing environment

 Preferred Requirements 

• High School Diploma/GED
• 4 years of maintenance experience in a pharmaceutical or similar manufacturing setting
• Experience with Computerized Maintenance Management Systems (CMMS)
• Knowledge of mechanical, electrical, and control systems
• Knowledge of GMP requirements
• Effective communication, both written and oral
• Ability to work in a team environment
• Knowledge of lean manufacturing principles
• Strong problem-solving and time management skills
• Ability to train and mentor others
• Certified Maintenance & Reliability Professional, Certified Maintenance & Reliability Technician, or certification in another relevant field

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. 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. 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 50 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.