Overview 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. 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.
External US
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 Processes (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
Who You Are
You will perform calibrations to instrumentation and controls. You are able to assist in the development of maintenance and calibration procedures and programs. You will be responsible for ensuring the efficiency and operational reliability of the instrumentation and controls for the facility equipment.
Basic Requirements
- High School Diploma/GED
- 6 years of I&C experience or similar field
- Experience in a GMP or another regulated environment
- 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
Preferred Requirements
- 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
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
- Will work in environment operating a motor vehicle or Powered Industrial Truck
- Ability to ascend or descend ladders, scaffolding, ramps, etc
- Ability to stand for prolonged periods of time
- Ability to sit for prolonged periods of time
- Ability to operate machinery and/or power tools
FDBN works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 - 130 and Export Administration Regulations in 15 C.F.R. Part 730 - 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.
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 .
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.