Manufacturing Support Associate 1, Documentation

Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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 a culture that fuels purpose, energy, and drive—what we call Genki. Job Description What you’ll do During The Project Phase Lead operational readiness initiatives that prepare teams, processes, and systems for start‑up. Lead site commissioning and qualification efforts to ensure facilities and equipment are ready for compliant use. In Operations Support and participate in troubleshooting within assigned process areas to quickly resolve issues and minimize downtime. Perform documentation updates to maintain accurate, compliant records and enable reliable production. Create non‑batch activities and develop associated documentation for technology transfer, changeover, preventive maintenance plans (PMs), and column packing. Support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities that strengthen manufacturing performance. Support inspections and audits by providing requested manufacturing documents and data. Perform other duties as assigned to meet production and quality goals. Minimum Qualifications High School Diploma or GED and 4 years of related experience; or Associate degree in life sciences and 2 years of direct experience; or Bachelor’s degree (BA/BS) in life sciences with no experience; or Equivalent military training/experience Skills and Abilities Strong verbal and written communication skills Expertise in Microsoft Office, especially Word Strong time management; ability to meet deadlines Ability to adapt in a fast‑paced environment and pivot as priorities change Critical thinking and superior problem‑solving skills Team‑based mindset; ability to build relationships and work effectively in a global team environment Ability to update and create documents on schedule with high attention to detail Preferred Qualifications Previous current Good Manufacturing Practice (cGMP) manufacturing operations experience Understanding of change management, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) BioWorks or BTEC Capstone cGMP coursework Pharmaceutical manufacturing experience Why this role matters Make a direct impact on reliable, compliant manufacturing outcomes Grow expertise across documentation, troubleshooting, and operational excellence Collaborate with cross‑functional teams in a dynamic, mission‑driven, 24/7 environment Ready to build your manufacturing career on a strong documentation foundation? Apply today. 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 (View email address on click.appcast.io). #J-18808-Ljbffr FUJIFILM Biotechnologies