Manufacturing Support Associate III, Tech Transfer
Listed on 2026-09-20
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, Production QC/QA
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 OverviewFUJIFILM 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:
Job DescriptionAbout 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…
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