Manufacturing Support Associate III, Tech Transfer

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

Help build reliable, compliant manufacturing from day one. As a Manufacturing Support Associate 3, Tech Transfer, you’ll be a hands-on process expert who leads operational readiness, drives troubleshooting, and keeps production running smoothly in a 24/7 facility—while upholding the highest standards of safety, quality, and documentation.

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

Requirements

• 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; OR
• Equivalent military experience or training
• Expertise in manufacturing operations
• High degree of troubleshooting ability
• Strong technical experience with batch planning and creation of manufacturing documentation
• Experienced with audits, leading investigations support, and leading continuous improvement projects
• Consistently works on complex assignments requiring independent action and initiative; makes recommendations for new procedures

Nice To Haves

• Associate’s or Bachelor’s Degree, preferably in life sciences or engineering
• BioWorks or BTEC Capstone cGMP coursework

Responsibilities

• Lead operational readiness during project phases: Drive site commissioning and qualification efforts; help establish methods, procedures, and readiness criteria for new or modified processes.
• Serve as a process subject matter expert (SME): Lead troubleshooting in your assigned area(s); resolve complex issues creatively and effectively; escalate and communicate risks promptly for high-severity events.
• Coordinate and optimize batch planning: Create and import process templates; align plans with preventive maintenance (PM) schedules to minimize downtime and ensure equipment readiness.
• Own and improve documentation: Recommend, create, and update manufacturing documentation (e.g., SOPs, batch records, work instructions) in compliance with change control.
• Enable training and onboarding: Initiate/support training programs, onboarding, and curriculum development and management to build and sustain operational capability.
• Manage non-batch activities: Coordinate changeovers, PMs, and column packing; generate associated documentation and ensure clear, accurate records.
• Support technology transfer: Contribute to process mapping, acceptance criteria, engineering runs, and capture lessons learned.
• Drive quality and continuous improvement: Initiate/support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities. Identify and/or drive highly technical improvement projects in DSM.
• Support audits and inspections: Prepare evidence, respond to observations, and implement sustainable actions.
• Collaborate and communicate: Act independently to determine methods and procedures on new assignments; often serve as facilitator or team lead to align cross-functional stakeholders.
• Maintain safety and compliance: Follow all safety regulations and procedures; uphold data integrity and documentation standards; maintain accurate production and equipment records.
• Flexibility: Work in a 24/7 operational environment; adapt to varying schedules as needed to support production.

Benefits

• Competitive compensation with opportunities for progression based on impact
• Comprehensive health coverage options
• Retirement savings program with company contribution
• Paid time off, holidays, and leave programs (including parental and caregiver leave)
• Shift and/or schedule differentials where applicable in a 24/7 environment
• Education assistance, professional development, and training opportunities
• Employee wellness resources and employee assistance program
• Inclusive workplace culture, recognition programs, and community engagement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED