Manufacturing Support Associate 3

Manufacturing Support Associate 3

The Manufacturing Support Associate 3 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

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

• Supports reliable production through the following activities during regular operations

• Leads troubleshooting including acting as a process subject matter expert (SME) for their process respective area(s)

• Coordinates Batch Planning including process template creation and import and management of preventive maintenance plans (PMs)

• Recommends and performs Documentation updates

• Initiates and/or supports training, onboarding, and curriculum development and management

• Coordinates non-batch activities and creation of associated documentation for changeover, PMs, column packing

• Supports tech transfer

• Initiates or supports change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities

• Identifies and/or drives highly technical improvement projects in DSM

• Supports inspections and audits

• Performs other duties, as assigned

Basic Requirements

• High school diploma with 8 years related experience

OR

• Associate's Degree with 6 years of direct experience

OR

• BS/BA with 4 years of direct experience

• Equivalent military experience or training

Preferred Requirements

• Associates or Bachelor's Degree preferably in life sciences or engineering

• BioWorks or BTEC Capstone cGMP coursework preferred

Physical Requirements

Physical Demands

• Ability to discern audible cues

Working Environment

Physical Demands

• 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 wrist, hands and/or fingers

• Ability to conduct work that includes moving objects up to 10 lbs

Environmental Conditions

• 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