Sr. Manufacturing Project Lead

Fujifilm•Holly Springs, NC

10d

About The Position

The Senior Manufacturing Project Lead leads and organizes manufacturing projects and support activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. 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 What You’ll Do During the Project Phase Leads operational readiness initiatives as well as site commissioning and qualification efforts Manages cost and schedule execution of project delivery items and manufacturing operational projects Supports organization and development of operational readiness In Operations: Leads manufacturing focused projects at the request of leadership Actively participates and collaborates to meet the need and expectations set forth by Factory X initiatives and other cross site projects, as assigned Supports materials management within manufacturing Drives column packing and changeover activities including the generation of documents Leads manufacturing support items which could include, but not limited to: Manufacturing change controls and corrective and preventive actions (CAPAs) Short flow investigations and alert/action limits Finite manufacturing schedules Continuous improvement, escalation, and mitigation of manufacturing issues Cross site or local manufacturing projects Technology transfer manufacturing deliverables Assist in regulatory inspections and audits Perform other duties as assigned

Requirements

High school diploma/GED with 12 years of related experience OR
Associate degree in life sciences or engineering with 10 years of direct experience OR
Bachelor’s degree in life sciences or engineering with 8 years of direct experience OR
Equivalent Military experience/training

Nice To Haves

Previous experience in cGMP manufacturing environment
Relevant experience in CAPEX/ OPEX projects
Ability to lead teams, facilitate workshops and effectively communicate project status
Experienced in campaign lifecycle activities
Understanding of manufacturing equipment, operations, and cadence
Bioworks or BTEC Capstone cGMP coursework preferred

Responsibilities

Leads operational readiness initiatives as well as site commissioning and qualification efforts
Manages cost and schedule execution of project delivery items and manufacturing operational projects
Supports organization and development of operational readiness
Leads manufacturing focused projects at the request of leadership
Actively participates and collaborates to meet the need and expectations set forth by Factory X initiatives and other cross site projects, as assigned
Supports materials management within manufacturing
Drives column packing and changeover activities including the generation of documents
Leads manufacturing support items which could include, but not limited to: Manufacturing change controls and corrective and preventive actions (CAPAs) Short flow investigations and alert/action limits Finite manufacturing schedules Continuous improvement, escalation, and mitigation of manufacturing issues
Cross site or local manufacturing projects
Technology transfer manufacturing deliverables
Assist in regulatory inspections and audits
Perform other duties as assigned