Senior Process Engineer 1

Position Overview

A Sr Process Engineer 1 provides engineering technical guidance with limited or no direction, primarily 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 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 facility.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By 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're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Job Description

What You'll Do:

• Serves as a technical leader in the 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, manufacturing, etc.
• 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 project(s) 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 the 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, as required
• 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
• Other duties, as assigned

Minimum 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 Requirements:

• Prior experience working in a cGMP environment or other highly

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on hirelifescience.com).