Manufacturing Support Associate III, Tech Transfer

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Manufacturing Support Associate 3, Tech Transfer to lead operational readiness, drive troubleshooting, and keep 24/7 production running safely and compliantly.

The role collaborates with operations, quality, engineering, and maintenance to develop methods, document changes, and support tech transfer while upholding rigorous GMP standards.

Qualifications

• Experience in manufacturing operations and GMP environments.
• Ability to troubleshoot complex process issues and implement effective corrective actions.
• Experience creating/managing manufacturing documentation, SOPs, and change controls.

Responsibilities

• Lead operational readiness during project phases and establish methods, procedures, and readiness criteria for new or modified processes.
• Serve as a process SME; lead troubleshooting and communicate risks for high-severity events.
• Coordinate and optimize batch planning; align with preventive maintenance to minimize downtime and ensure equipment readiness.
• Own and improve documentation; create/update SOPs, batch records, and work instructions under change control.
• Enable training and onboarding; develop and manage curricula for operational capability.
• Manage non-batch activities like changeovers and PM documentation.
• Support technology transfer; contribute to process mapping and acceptance criteria.
• Drive quality and CI initiatives; support CAPAs and continuous improvement projects.
• Support audits and inspections with evidence and responses; implement sustainable actions.
• Collaborate with cross-functional teams and operate independently on new assignments.

Skills

Manufacturing operations

Troubleshooting

Batch planning

Documentation

Training/onboarding

Cross-functional collaboration

Safety/compliance

Education

BS/BA in life sciences or engineering

Associate degree

Equivalent military experience

Job description

Position Overview

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.

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

About Us We are a dynamic, round‑the‑clock manufacturing site committed to safe, compliant, and reliable production. Our teams collaborate across operations, quality, engineering, and maintenance to deliver consistent results, support inspections/audits, and continuously improve how we work. We value curiosity, accountability, and inclusivity—and we equip our people to lead with both technical depth and practical know‑how.

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; elevate 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.

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; OR
• 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

Knowledge, skills, and abilities

• 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

Work environment and physical requirements

• May work in mechanical/production spaces that require hearing protection and enrollment in a hearing conservation program
• Ability to discern audible cues
• Ability to stand and sit for prolonged periods; perform repetitive motions with wrists, hands, and/or fingers
• Ability to conduct work that includes moving objects up to 10 lbs routinely (and up to 33 lbs as needed)
• Ability to operate in areas requiring ascent/descent of heights greater than 4 feet
• Ability to bend, push/pull, and reach between approximately 18" and 60"
• May require respiratory protection (as applicable to task)
• No routine operation of motor vehicles or powered industrial trucks in this role
• Visual acuity requirement does not mandate 20/20 corrected vision for this position
• Typically not exposed to extreme hot/cold environments, outdoor elements, small/enclosed spaces, or ladders/scaffolding

Benefits We offer a comprehensive, competitive, and inclusive rewards package designed to support your well‑being and growth. Benefits typically include:

• 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

We are an equal opportunity employer. We value diversity in all its forms and welcome candidates of all backgrounds and experiences. If you’re excited about leading reliable production and elevating operational excellence, we’d love to hear from you.

EEO Information

Fujifilm is committedto 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]).