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.
External US
About This Role
The Tech 2, 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.
What You’ll Do
Performs intermediate instrumentation and controls troubleshooting, repairs, preventive and corrective maintenance to all site equipment, systems, process measurement and control, utility, laboratory, and bench-top instrumentationPerforms calibrations to instrumentation and controlsFollows standard procedures and protocols to ensure compliance with safety and Good Manufacturing Processes (cGMP) quality standardsProvides input and recommendation for written instruction of preventive maintenance tasks and standard operating procedures (SOPs)Assists in the development of maintenance and calibration procedures and programsPerforms loop checks for new instrumentation to ensure proper functionalityPerforms lock out tag out (LOTO) as required to complete I&C/Metrology activitiesMentors’ entry-level techniciansAdheres to all safety requirements and follow safe work practicesNotifies management or Environmental Health & Safety (EHS) when unsafe conditions or hazards are foundSupports site operations and emergency work orders during off-hours, as neededPerforms spare parts assessments, as requiredOther duties, as assignedWho 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/GED4 years of I&C experience or similar fieldExperience with GMP requirementsKnowledge of mechanical, electrical, and control systemsEffective communication, both written and oralAbility to work in a team environmentKnowledge of lean manufacturing principlesMust be able to work shifts and on-call, as neededPreferred Requirements
Associates degree in Mechanical, Electrical, or Chemical Engineering or a related field5+ years of maintenance experience in a pharmaceutical or similar manufacturing environmentExperience with Computerized Maintenance Management System (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 programWill work in environment operating a motor vehicle or Powered Industrial TruckAbility to ascend or descend ladders, scaffolding, ramps, etcAbility to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to operate machinery and/or power toolsFDBN 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 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.
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