Instrumentation & Controls Engineer

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. 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.

We are looking for an Instrumentation & Controls Engineer, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. The I&C Engineer will be responsible for providing guidance during the design on I&C concepts and ensuring site wide coordination of I&C design solutions and clonability to other sites globally.  In addition, the I&C Engineer will be responsible for participating in the Factory Acceptance Testing, startup and commissioning activities of the I&C systems through the facility.  During operations, the I&C engineer will support the calibration team and manufacturing processes with regards to instrumentation and control systems. The I&C Engineer will have close cooperation with project teams and relevant departments for providing technical knowledge and support to installation of new equipment and implementation of new instrumentation.  

We are looking for a person with positive energy, entrepreneurship, and courage to empower and inspire others while utilizing your extensive knowledge and knowhow. 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.

External US

Job Responsibilities

• Provide technical expertise for I&C systems during Factory Acceptance Testing (FAT), system walkdowns, startup and commissioning.
• Collaborate with vendor partners on construction aspects of I&C components and systems. 
• Review and approve submittals with respect to I&C designs.
• Ensure site wide coordination of I&C design solutions.
• Review and participate in 3D model reviews of facility and large equipment modules, work with master planners in assessing degree of I&C progress and accessibility.
• Partner with the process engineering team and automation team to establish proper instrument data, ranges, spare parts, etc.
• Partner with the Metrology group to establish calibration procedures and ranges, as well as support troubleshooting and repairs.
• Manage instrumentation data in DCS/BMS and CMMS systems.
• Coordinate with internal and external partners and stakeholders to ensure alignment across the site
• Ensure deliverables meet all quality and compliance standards  
• Propose and/or implement changes within the I&C area of responsibility

Preferred Requirements

• Experience in establishing a processes and procedures from similar role in industrial I&C projects. 
• Experience in a cGMP facility or working with FDA regulations or similarly regulated industry.
• Experience in instrument selection, controls interfaces
• Thorough understanding of the impact of the role on a GMP facility
• Process Analytical Technology experience is a plus.

 Basic Requirements

• 10+ years of I&C experience  
• Thorough knowledge in both instrument sensors and final control elements.
• Collaborative attitude with the willingness to work with global peers toward company and department goals. 
• Excellent oral and written communications skills in English

FDBU 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.

FDBU 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.