Manufacturing Support Associate 1, Documentation

Position Overview Help power a world‑class, 24/7 manufacturing operation by ensuring production runs safely, compliantly, and on schedule. As a Manufacturing Support Associate I with a documentation focus, you’ll be at the heart of operational readiness, record accuracy, and continuous improvement‑enabling teams to deliver life‑changing products with confidence. 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: 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. *#LI-Onsite 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 Merck & Co. Inc