Sr. Manufacturing Project Lead

Senior Manufacturing Project Lead

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."

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

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

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 (FDBN_PNC@fujifilm.com).

Job Locations US-NC-Holly Springs

Category Manufacturing

Company (Portal Searching) FUJIFILM Biotechnologies