Senior Clean Utilities Engineer-SME

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.

Join us

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 This Role

The Senior Clean Utilities Engineer is the Subject Matter Expert (SME) and provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electronic data interchange (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role provides ownership for the assigned clean utility systems and partners with other stakeholders in the operation of owned systems. This role works directly with other Utility Engineers to ensure applicable safety and regulatory standards are maintained, identify process improvements, and assist with troubleshooting equipment issues to maintain overall plant reliability. Additionally, this role supports deviation investigations and mentors' other engineers, as needed across a spectrum of engineering disciplines.

External US

What You’ll Do

• Spearheads the team within assigned discipline through activities (e.g., system startup and troubleshooting, maintenance and upgrades, specification review, Factory Acceptance Tests (FATs) and visits, equipment installation, and issue resolution) are performed to the company standards
• Develops Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline
• Performs and provides guidance for deviations and change controls resolutions and closures
• Reviews submittals, installation, and testing of equipment within assigned discipline across all buildings onsite
• Performs field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings
• Reviews and approves Preventative Maintenance templates for equipment within assigned discipline
• Partners with Utility Operators and Maintenance Technicians to resolve operational issues
• Leads the development for User Requirements Specification (URS) and Standard Operating Procedures (SOPs), equipment maintenance and troubleshooting in assigned systems
• Contributes to the development for various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
• Reviews equipment and system trends and provides recommendations to management for improvement
• Participates in the implementation of maintenance strategies to maximize equipment reliability
• Leads small teams through system design changes
• Maintains system and equipment maintenance requirements, schedules, and execution
• Maintains Good Manufacturing Practices (GMP) compliance aspects of validated systems
• Participates in audits with customer representatives and regulatory agencies
• Provides guidance and mentorship to junior Engineers, as needed
• Provides engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.)
• Communicates updates to site leadership on key technical efforts, strategic initiatives, and other relevant information
• Troubleshoots simple and complex system challenges and makes complex decisions across the site within assigned discipline
• Cross-trains on multiple disciplines to assist the larger Engineering team with achieving deliverables
• Collaborates with other departments (e.g., Utility Operations, Manufacturing, and Validation)
• Other duties, as assigned

Who You Are

You will be the Subject Matter Expert (SME) and provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electronic data interchange (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems.

Basic Requirements

• Bachelor’s degree in Engineering or related field with 8 years of experience with process utility systems and components in an industrial environment
• Experience working in a current Good Manufacturing Practices (cGMP) or other highly regulated environment
• Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations
• Effective communication, both written and verbal
• Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint)
• Ability to analyze and troubleshoot simple to moderate system and component related issues
• Ability to coordinate and facilitate effective small cross-functional teams
• Ability to mentor and guide junior-level Engineers

Preferred Requirements

• Masters Degree in Engineering, Business Management, or related field with 6 years of experience with process utility systems and components in a cGMP environment or other highly regulated environment
• Professional Engineer (PE) License

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection. X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

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 ascend or descend ladders, scaffolding, ramps, etc. No X Yes

Ability to stand for prolonged periods of time. No X Yes 60 minutes

Ability to sit for prolonged periods of time. No X Yes 240 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes

Ability to operate machinery and/or power tools. No X Yes

Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.

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

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 FDBN_PNC@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.