Manufacturing Support Associate 3, Training

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Manufacturing Support Associate 3, Training (Downstream Manufacturing). This hands-on technical leader drives operational readiness, leads troubleshooting, and champions training and documentation excellence—enabling safe, consistent, on-time production.

You will join a dynamic biomanufacturing site focused on 24/7 operations, collaborating across teams to deliver high-quality products while maintaining compliance and continuous

Qualifications

• High school diploma with 8 years of related experience or
• Associate’s or BS/BA with required direct experience in manufacturing
• Experience in cGMP environments and documentation practices preferred
• Military experience or training equivalent may be accepted

Responsibilities

• Lead operational readiness during project phases, including site commissioning and qualification efforts.
• Serve as a process SME and lead troubleshooting to sustain reliable operations.
• Coordinate batch planning, build process templates, import plans, and manage preventive maintenance schedules.
• Recommend and update manufacturing documentation to keep procedures current, clear, and compliant.
• Initiate or support training programs, onboarding, and curriculum development and management.
• Coordinate non-batch activities and documentation for changeover, PMs, and column packing.
• Support technology transfer activities to enable smooth scale‑up/scale‑down.
• Initiate or support CAPAs and CI initiatives to drive continuous improvement.
• Identify and drive highly technical improvement projects within Downstream Manufacturing.
• Support inspections and audits with accurate documentation and clear communication.
• Collaborate cross‑functionally and define methods on new assignments.
• Perform other duties to meet manufacturing goals in a 24/7 environment; flexible hours may be required.

Skills

Troubleshooting

Batch planning

Documentation management

Training program development

Cross-functional collaboration

Education

BS/BA in life sciences or engineering

Associate’s degree

High school diploma with experience

Equivalent military experience

Job description

Help power reliable, compliant, 24/7 biomanufacturing. As a Manufacturing Support Associate 3, Training (Downstream Manufacturing), you’ll be a hands‑on technical leader who drives operational readiness, leads troubleshooting, and champions training and documentation excellence—so teams can produce safely, consistently, and on time.

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

• We are a dynamic, around‑the‑clock biomanufacturing site focused on delivering high‑quality products with safety and compliance at the core.
• You’ll join a collaborative team that values continuous improvement, knowledge‑sharing, and practical problem‑solving.
• We welcome people from all backgrounds and experiences and provide equitable opportunities for growth and impact.

Responsibilities

• Lead operational readiness during project phases, including site commissioning and qualification efforts.
• Serve as a process subject matter expert (SME) for your area(s); lead troubleshooting to restore and sustain reliable operations.
• Coordinate batch planning, including building process templates, importing plans, and managing preventive maintenance (PM) schedules.
• Recommend and perform updates to manufacturing documentation to keep procedures current, clear, and compliant.
• Initiate and/or support training programs, onboarding, and curriculum development and management to build team capability.
• Coordinate non‑batch activities and documentation for changeover, PMs, and column packing.
• Support technology transfer activities to enable smooth scale‑up/scale‑down and process adoption.
• Initiate or support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) initiatives.
• Identify and/or drive highly technical improvement projects within Downstream Manufacturing (DSM) to enhance safety, quality, and efficiency.
• Support internal and external inspections and audits with accurate documentation and clear communication.
• Collaborate cross‑functionally; act independently to define methods and procedures on new assignments.
• Perform other duties as assigned to meet manufacturing goals in a 24/7 environment; flexibility with working hours may be required.

Minimum Qualifications (must‑have)

• High school diploma with 8 years of 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 Qualifications

• Associate’s or Bachelor’s degree, preferably in life sciences or engineering
• BioWorks or BTEC Capstone cGMP coursework
• Expertise in manufacturing operations with a high degree of troubleshooting ability
• Strong technical experience with batch planning and creation of manufacturing documentation
• Experience with audits, leading investigation support, and leading continuous improvement projects

Benefits

• Competitive compensation with potential shift flexibility to support a 24/7 operation
• Comprehensive health and wellness coverage (medical, dental, vision) and employee assistance resources
• Retirement savings plan with company support
• Generous paid time off, paid holidays, and leave programs
• Learning and development opportunities, including training, certifications, and cross‑functional exposure
• Safety‑first culture with robust PPE programs and resources
• Inclusive workplace with equal opportunity practices and reasonable accommodations for qualified individuals

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 ([e-mail]).