Senior Process Engineer 1

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We offer a dynamic work environment and cultivate a culture that fuels purpose, energy, and drive—what we call Genki.

About the role

As a Sr Process Engineer, you will provide engineering technical guidance with limited or no direction, focusing on client process fit within existing facility designs and specifying equipment and facility gaps for Drug Substance (DS) and Drug Product (DP) processes. This role champions the transformation of engineering, manufacturing, and facility technologies, participates in industry forums, and provides technical engineering expertise for new processing equipment designs, installations, and modifications to existing equipment and facilities.

Responsibilities

• Serves as a technical leader in client facility fit assessment and process design for equipment, facility, and operational capabilities
• Manages assessments and feasibility studies for prospective new and expanded capabilities for equipment and manufacturing
• Drives engineering studies to confirm process fit to plant for new processes and changes to existing processes
• Provides equipment design expertise and advice to guide major projects or other activities
• Leads equipment capital expenditure estimates
• Supports development of procurement packages by partnering with Project Engineering
• Identifies gaps, provides suggestions, and drives implementation of improvements within the Drug Substance (DS) and Drug Product (DP) manufacturing area
• Partners with Process Engineering/Science teams as a lead for identifying process optimizations and potential bottlenecks
• Interacts with senior internal and external personnel on significant matters and cross-functional coordination
• Provides regular updates to senior leadership on strategic initiatives, key technical efforts, facility fits, and investments
• Serves as subject matter expert (SME) for process equipment & technologies, including upstream and downstream processes
• Supports site expansion project planning and future design
• Leads transition into technology transfer (detailed mass balance, equipment flow diagrams, and technical consultation)
• Provides support to Program Management, Manufacturing, Technical Operations, EH&S, etc., concerning new client processes and equipment, as needed
• Performs other duties, as assigned

Requirements

• Bachelor’s degree in Engineering or a related field with 8 years of Engineering or other relevant technical work experience; or Master’s degree in Engineering or a related field with 6 years of Engineering or other relevant technical work experience
• Experience with DS or DP process equipment and unit operations

Preferred Qualifications

• Prior experience working in a cGMP environment or other highly regulated industry