Associate Manager, Utility Operations

Overview:

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

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

This will be the largest end-to-end cell culture CDMO provider in North America.

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

External US:

About This Role

The 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 site

Additionally, this role provides day-to-day oversight and development of the Utilities team.

• 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 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%

• 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

• 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 Requirements

Ability to discern audible cues. No X Yes

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes

If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.