Overview

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. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Summary: The Maintenance Planner/Scheduler under the supervision of the Maintenance Systems Supervisor is responsible for the planning, scheduling and performance of the maintenance program including, but not limited to the Drug Substance Manufacturing (DSM) and Drug Product/Finished Goods (DPFG) buildings. Primary responsibilities include managing the daily maintenance operations such as screening of incoming work orders, identification of job requirements, procurement of equipment and specialized tools, scheduling of maintenance staff, parts inventory control and monitoring of maintenance tasks performance. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations technicians, validation, quality and external suppliers to provide a high level of excellence over the maintenance operational activities of FDBN.

External US

Essential Functions:

• Responsible for taking a leadership role in the day-to-day activities of the Maintenance Operations (Planning, Scheduling, etc.).
• Responsible for the planning, scheduling and performance of the maintenance program.
• Responsible for conducting field walk downs to identify and document job requirements.
• Responsible for making available permits and safety procedures required for the job execution.
• Procurement of equipment and specialized tools required to perform the work.
• Responsible for evaluating 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 for collaborating with maintenance supervisors to schedule staff for the execution of maintenance activities.
• Responsible to maintain equipment bill of materials to cover planned maintenance activities.
• Communicate with technical trades regarding ideas and procedures that would make future jobs more efficient.
• Meet with internal customers to plan and schedule calibrations and maintenance activities across multiple facilities.
• Work directly with Manufacturing, Utilities, Quality Assurance, Maintenance, Facilities, and Quality Control to support their individual department needs regarding to planning & scheduling.
• Responsible for developing, writing, editing and/or reviewing SOPs.
• Monitor and provide input to departmental KPIs.
• Maintain a positive, professional, and customer-oriented attitude.

Required Skills & Abilities:

• Knowledge of a wide variety of typical maintenance tasks, including preventative maintenance, 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 Calibration & Maintenance Management Systems (CCMS/CMMS), preferably INFOR.
• Strong leadership skills, written and verbal communications skills, self-motivation and interpersonal skills.
• Ability to learn quickly and work effectively with little supervision.
• Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems.​
• Capable of handling multiple priorities quickly and efficiently, and delegate tasks to appropriate trades and skill levels.
• 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.
• Demonstrate a pursuit of increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.
• Working knowledge of MS Office products (Word, Excel, Outlook, Teams, and PowerPoint).
• Basic knowledge of cGMP and cGDP requirements and procedures.

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 a computer keyboard, telephone, calculator, and other office equipment is required.
• Have a normal range of vision.
• May be required to lift up to 50 pounds on occasion.
• Climb ladders and stairs of various heights.
• Be exposed to wet or humid conditions.
• This position may include On-Call response for Facility issues.
• Be exposed to outdoor weather conditions.
• Be exposed to noisy environments.
• Attendance is mandatory.

Qualifications:

• Bachelor's degree in a related discipline with a minimum of 3 years of overall experience on which at least 2 years must be in a cGMP, FDA, or other regulated operation; OR
• Associate’s degree in a related discipline with a minimum of 5 years of overall experience on which at least 3 years must be in a cGMP, FDA, or other regulated operation; 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 on which at least 4 years must be in a cGMP, FDA, or other regulated operation.

Preferred Qualifications:

• Experience working in a biotechnology facility is preferred.
• Experience in Start-Up & Commissioning of cGMP Facility.

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 lena.lee@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.