Sr. Manufacturing Project Lead

Position Overview

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.

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:

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

Basic 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

Preferred Requirements

• 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

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds
• Will work in heights greater than 4 feet

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.

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.

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 ().