Manager, Process Engineering

Position Overview

The Manager, Process Engineering is responsible for leading the Upstream and Downstream Drug Substance Manufacturing (DSM) Process Engineering team and activities from inoculation through bulk fill. The Manager utilizes their technical expertise with process equipment and processes to provide support and direction on technical topics. This role applies their leadership experience to oversee and manage a team of experienced and developing engineers supporting operations, technology transfers (TT), and projects on time and within budget. Additionally, the Manager drives site engineering goals and deliverables ensuring the successful manufacturing operations.

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

• Fosters and sustains a people first culture where the team feels valued, respected, and supported through servant leadership
• Implements the strategy for Process Engineering in close collaboration with stakeholders and Large-Scale Business Unit counterparts
• Builds and leads a high-performing Process Engineering team while encouraging a culture that prioritizes continuous learning and development through coaching and mentoring
• Owns departmental operations – budget, systems, workflows, and resource planning to deliver on time and within budget
• Manages a team to lead, develop, and implement technically sound and fit-for-purpose policies and procedures based on current regulations, industry standards and practices for DSM, process and TT, and equipment validatio
• Provides leadership and direction to the manufacturing site to define the equipment requirements for execution of clients manufacturing processes
• Seeks to continuously optimize the manufacturing processes and equipment to ensure effective use of capacity and minimize costs
• Partners with Client, MSAT, Quality, and Manufacturing on new technology introduction, scale-up, and manufacturability as part of TT, as needed
• Participates in TT stage gate reviews on incoming processes/changes ensuring the change is ready for introduction to manufacturing and manufacturability of the process
• Establishes systems and procedures to enable proactive equipment monitoring, analysis, and reporting
• Functions as the senior leader for client projects, translating complex process data into clear and concise technical explanations and status updates, and supports equipment evaluations and risk assessments
• Provides team support for critical manufacturing investigations and technical oversight of deviations, change controls, corrective and preventive actions (CAPAs)
• Assesses, communicates, and mitigates key manufacturing equipment risks
• Oversees process engineering, process equipment, instrument care, maintenance, troubleshooting, and data interpretation
• Evaluates team performance, implements measures to improve productivity and engagement, and partners with People & Culture to recruit and retain talent
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor’s degree in engineering or related discipline with 6+ years in an engineering role (4+ in the life science industry); or Master’s degree in engineering or related discipline with 4+ years in an engineering role in the life science industry
• 4+ years of experience managing people
• Prior experience in Greenfield site startup
• Prior experience in cell culture, centrifugation, chromatography, TFF, and depth filtration
• Experience working in a changing, project driven organization

Preferred Requirements:

• Large capital expenditure experience
• Prior experience working in a Greenfield site
• Experience collaborating with global colleagues

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 ([email protected]).