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.
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 the Role
The CMMS Administrator under the supervision of the Sr. Supervisor Maintenance Systems is responsible for maintaining and developing the Computerized Maintenance Monitoring System (CMMS) for the Fujifilm Diosynth Biotechnologies site in Holly Springs, NC. The successful candidate will perform site wide implementation of the CMMS system, maintain equipment inventory – data entry for new and existing equipment, generate labels and update maintenance schedules or job plans. You will conduct training and Information Sessions- Provide training and or information on the CMMS program for maintenance team members. Generate Reports – generate customized, standard, and ad-hoc reports, ensuring they are issued within time frames. You will interact with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance operational activities of FDBN.
•Responsible to conduct field walk downs to identify and document job requirements.
•Responsible to make available permits and safety procedures required for the job execution.
•Procurement of equipment and specialized tools required to perform the work.
•Responsible to evaluate the need for replacement parts required to perform the work.
•Estimate required hours on work order tasks, total work order duration and skills required to perform the task.
•Responsible to work in conjunction with maintenance supervisors the schedule of staff for the execution of maintenance activities.
•Responsible to maintain equipment bill of materials to cover planned maintenance activities.
•Meet with internal customers in order to plan and schedule calibration and maintenance activities for their instrumentation and equipment across multiple facilities.
•Maintain workload balance across the Metrology and Maintenance Departments and monitors department labor utilization.
•Support other team members and system users on issues pertaining to the CCMS/CMMS system.
•Work directly with Manufacturing, Validation, Quality Assurance, Metrology, Maintenance, Facilities, and Quality Control in order to support their individual department needs.
•Responsible for developing, writing, editing and/or reviewing SOPs for the maintenance operations.
•Be able to handle multiple priorities quickly and efficiently, and delegate tasks to appropriate trades and skill levels.
•Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.
•Able to work in a large team environment and build cooperative, collaborative relationships with field teams.
•Maintain a positive, professional, and customer-oriented attitude.
Required Skills & Abilities:
•Knowledge of a wide variety of typical maintenance tasks, including PM, spare parts, work order lifecycle and troubleshooting systemic problems. General principles of engineering, operations and the tools and equipment required to perform many of the daily maintenance tasks.
•Strong knowledge of Computerized Maintenance Management Systems (CCMS/CMMS), preferably INFOR.
•Strong written and verbal communications skills be self-motivated and possess interpersonal skills.
•Ability to learn quickly and work effectively with little supervision when needed.
•Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems.
•Ability to coordinate, facilitate and organize resources in an efficient manner.
•Ability to work effectively under extreme pressure to meet deadlines.
•Well organized and detail oriented with ability to handle multiple activities simultaneously.
•Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
•Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint).
•Knowledge of cGMP and cGDP requirements and procedures.
•This role will require a high level of personal organizational skills, experience and drive.
•Bachelor's degree in a related discipline with a minimum of 3 years of overall experience. At least 2 years in a cGMP or other FDA regulated operation is preferred; OR
•Associate's degree in a related discipline with a minimum of 5 years of overall experience. At least 3 years in a cGMP or other FDA regulated operation is preferred; OR
•High School Diploma with some additional technical education or training in a college or university with a minimum of 7 years of overall experience. At least 4 years in a cGMP or other FDA regulated operation is preferred.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
•Experience prolonged sitting, standing, walking, bending, stooping and stretching.
•Use hand-eye coordination and manual dexterity sufficient to operate portable tools, test instruments, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
•Have a normal range of vision.
•The ability to regularly lift and/or move up to 50 pounds.
•Climb ladders and stairs of various heights.
•Be exposed to wet or humid conditions.
•Be exposed to outdoor weather conditions.
•Be exposed to noisy environments.
•This position will be on-call for maintenance issues in rotation with other technicians.
•This position may require coverage of different shifts, weekends and holidays.
The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.
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 email@example.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.