Manufacturing Support Associate 3

Position Overview Drive excellence in a fast-paced, 24/7 manufacturing environment. As a Manufacturing Support Associate III, you will lead critical readiness and operational activities that keep production compliant, reliable, and safe. You will serve as a process subject matter expert, coordinate complex planning, and champion improvements that elevate performance across the site. This facility operates around the clock; flexibility with working hours may be required. 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: Job Description What you'll do * Lead operational readiness initiatives to prepare people, processes, equipment, and systems for start-up. * Lead site commissioning and qualification efforts to ensure facilities and equipment are ready for compliant use. * Lead troubleshooting in assigned process areas, acting as a process subject matter expert to resolve issues, prevent recurrence, and minimize downtime. * Coordinate batch planning, including creating process templates and importing and managing preventive maintenance plans. * Recommend and perform documentation updates to keep records accurate, current, and aligned with process improvements. * Initiate and support training and onboarding; develop, manage, and improve curricula that build consistent capability across shifts. * Coordinate non-batch activities and create associated documentation for changeovers, preventive maintenance, and column packing. * Support technology transfer, ensuring seamless introduction and scale-up of processes within manufacturing. * Initiate or support change management records, investigations, corrective and preventive actions, and continuous improvement activities. * Identify and drive highly technical improvement projects in drug substance manufacturing to enhance reliability, yield, and throughput. * Support inspections and audits by preparing and providing required manufacturing documents and evidence of compliance. * Perform other duties, as assigned, to meet production, quality, and safety goals. Hands-on equipment responsibilities: * Operate advanced machinery used in production, including assembly lines, presses, and related equipment, to meet quality standards and production targets. * Set up and fine-tune machines, monitor production processes, and troubleshoot moderately complex technical issues; promptly alert colleagues of more complex issues or suspected faults. * Maintain accurate, timely production records and strictly follow all safety regulations and procedures. Knowledge, skills, and abilities * Expertise in manufacturing operations with a high degree of troubleshooting ability. * Strong technical experience with batch planning and the creation and maintenance of manufacturing documentation. * Experience supporting audits, leading investigation support activities, and leading continuous improvement projects. * Clear communicator with strong collaboration skills across operations, quality, and engineering. * Organized, detail-focused, and able to prioritize in a dynamic, around-the-clock environment. Minimum education and experience requirements * High School Diploma with 8 years of related experience; or * Associate's Degree with 6 years of direct experience; or * Bachelor's Degree with 4 years of direct experience; or * Equivalent military experience or training Preferred education and experience * Associate's or Bachelor's Degree, preferably in life sciences or engineering * BioWorks or BTEC Capstone current Good Manufacturing Practice coursework preferred Why you'll love this role * High-impact ownership: Lead readiness, troubleshooting, and continuous improvement that directly affects delivery and quality. * Technical growth: Build depth as a process expert while shaping training and documentation that scale best practices across shifts. * Team culture: Partner with skilled colleagues committed to safety, compliance, and operational excellence. Ready to lead on the manufacturing front line and keep world-class production running? Apply today. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. 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).