OverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe 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 usWe 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 USAbout This RoleThe Associate Manager of Utility Operations ensures the efficiency and operational reliability of the Utilities and Controls that support side-wide equipment and facility systems through Preventive and Corrective Maintenance practices. This role manages the development of the utility operators as the sitetransitions from construction to operation. This role also assists with establishing efficient programs designed fit for future operations by utilizing knowledge of current good manufacturing practice (cGMP) and good laboratory practice (GLP) compliance, utility operations and maintenance programs, work scheduling, and equipment repair and troubleshooting. Additionally, this role provides day-to-day oversight and development of the Utilities team.What You’ll Do
Assists with developing the team’s strategy and schedule needed for operations
Leads the transition from construction to operations for the utility systems by defining operational procedures and processes
Manages and develops utility technicians and operators across all aspects of personnel management
Collaborates with leadership to develop, implement, and perform tasks for the FDBN Utility Operations Program (e.g., establishes procedures, troubleshooting and repairs, access requirements, etc.)
Supports analysis of equipment breakdowns (failure analysis) to determine root cause and makes recommendations to eliminate future breakdowns
Participates on emergency response teams (ERTs) and other process improvement teams, as required
Leads root cause investigations and corrective and preventive actions (CAPAs)
Supports project engineering with design, installation, and validation of new plant system equipment, including facility, process, and laboratory utility systems
Interfaces with other maintenance and technical functions (e.g., Instrumentation & Controls, Manufacturing, Engineering, Spare Parts, Validation, Quality, and external suppliers) to provide a high level of excellence support
Acts as an operations advocate, removes barriers, enables processes to run optimally, and coordinates daily schedule
Serves as a coach and technical mentor for technicians and operators to foster professional development
Addresses employee concerns, questions, and performance, and partners with HR, as needed for resolution
Executes process confirmation of standards used on shift and works with process teams on ideas to proactively improve quality and compliance while implementing process improvements
Ensures control room technicians and operators follow processes through appropriate training and verifies solutions are mapped to work and communicated across shifts
Reviews and closes work orders completed by the utility operators and maintenance teams
Ensures operational tasks are properly documented in logbooks, pass downs, and work orders
Develops a process to ensure updates, changes, and any information is accurately communicated to all employees across shifts
Enforces all safety and environmental requirements and company policies (e.g., time off, shift work, inclement weather) that directly impact employees
Participates in the recruitment process and retention strategies to attract and retain talent
Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports, etc.)
Participates in site visits to FDB global locations for knowledge sharing and learning of best practices
Other duties, as assigned
Knowledge and Skills
Knowledge of operations and maintenance performed on GMP and non-GMP utility equipment
Knowledge of engineers and operations general principals, and tools or equipment associated with calibration
Effective communication, both written and oral
Strong analytical and problem-solving skills
Ability to work in a fast-paced environment
Ability to lead a team and manage multiple projects simultaneously
Knowledge of Microsoft Office (e.g., Word, Excel, Outlook, PowerPoint)
Ability to effectively present complex information to others
Ability to adapt and be flexible with schedule to effectively communicate and manage teams on shift
Flexibility to provide on-call support to 24/7 operations and maintenance teams
Travel required, up to 10%
Basic Requirements
High School Diploma/GED with 12 years of operations or maintenance experience; or
Associate degree in Engineering, Life Sciences, or relevant field with 10 years of operations or maintenance experience; or
Bachelor’s degree in Engineering, Life Sciences, or relevant field with 8 years of operations or maintenance experience
Experience working in a cGMP environment
1-2 years of managing a team of utility operators or technicians
Preferred Requirements / Certificates
Bachelor’s degree in Engineering, Life Sciences, or relevant field
Experience working in utility operations within the biotechnology or pharmaceutical industry
Lean Six Sigma or other process improvement certification
BioWork Certification
Working Conditions & Physical RequirementsWill work in environment which may necessitate respiratory protection. No X YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X YesWill work in environment operating a motor vehicle or Powered Industrial Truck. No X YesAbility to discern audible cues. No X YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X YesAbility to ascend or descend ladders, scaffolding, ramps, etc. No X YesAbility to stand for prolonged periods of time. No X Yes, up to 240 minutesAbility to sit for prolonged periods of time. No X Yes, up to 240 minutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers. No X YesAbility to operate machinery and/or power tools. No X YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X YesFDBN 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 FDBNPNC@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.Job Locations US-NC-Holly SpringsPosted Date 9 hours ago (10/21/2024 2:48 PM)Requisition ID 2024-28216Category OtherCompany (Portal Searching) FUJIFILM Diosynth Biotechnologies
