The work we do at FUJIFILM Diosynth Biotechnologies (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.

Sr. Supervisor Maintenance – Maintenance is responsible for ensuring the efficiency and operational reliability of the process equipment and systems through effective Preventive and Corrective Maintenance practices. As Senior Supervisor, you will be responsible for setting the direction and managing the development of the process maintenance teams as it transitions from construction to operational activities. As Senior Supervisor you will help in establishing an efficient program design fit for future operations by utilizing your experience with cGMP/GLP compliance, work scheduling and equipment repair/troubleshooting. Additionally, you will be responsible for providing day-to-day oversight and development of the process maintenance team. We are looking for a leader with positive energy and courage to empower and inspire others while utilizing your extensive knowledge and know how. You will join an organization focusing on growth, people and a steep learning curve as well as a diverse workplace with people driven to make a difference.

Responsibilities include but not limited to:

• Execute a maintenance strategy to ensure the safe and reliable operation of the pharmaceutical plant's equipment and systems
• Lead a team of maintenance technicians in troubleshooting and repairing equipment failures, conducting preventative maintenance, and performing equipment modifications and upgrades
• Develop and maintain maintenance procedures, work instructions, and standard operating procedures (SOPs)
• Ensure compliance with all applicable regulatory requirements, including FDA, cGMP, and OSHA regulations
• Ensure that all maintenance activities are carried out in a cost-effective manner
• Work closely with other departments, such as production, quality control, and engineering, to ensure that maintenance activities support the overall goals of the plant
• Identify opportunities for process improvements and lead projects to implement them

• Complete comprehension of the process equipment
• Provide leadership and supervision to maintenance teams.
• Troubleshoot, maintain & identify system improvements.
• Adhere to all Quality & Environmental & EH&S regulations within area of responsibility
• Maintain & establish standards for procedures & maintenance plans.
• Support all design, installation, commissioning, qualification, training activities for assigned area.
• Communicate and work alongside process operations and I&C teams.
• Develop & implement reliability driven maintenance & monitoring plans & practices, including oversight of 3rd party service provides

• Understanding of technical documents such as URS, SAT, FAT, Commissioning & Validation Protocols.
• Strong knowledge of Computerized Maintenance Management Systems (CCMS/CMMS), preferably INFOR.
• Strong written and verbal communications skills, be self-motivated and possess interpersonal skills.
• Strong analytical and problem-solving skills and experience with leading people in a process environment.
• Ability to coordinate, facilitate and organize resources in an efficient manner.
• Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
• 10% travel required
• Active passport needed

• Minimum of 10 years of experience in maintenance and reliability engineering in a pharmaceutical or other highly regulated industry.
• Strong understanding of cGMP regulations and their application to maintenance activities.
• Experience managing a team of maintenance technicians
• Strong problem-solving and analytical skills
• GED or High School Diploma required

Preferred experience:

• Bachelor's degree in engineering or a related field
• Experience with computerized maintenance management systems (CMMS)
• Six Sigma or other process improvement certification
• Experience with project management methodologies
• Familiarity with lean manufacturing principles

• 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.

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 glenna.gonzalez@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.