Digital Operations Associate/Digital Operations Specialist 1/2 (Experience Based)

Position Overview The Digital Operations Specialist 1 is an early-career professional responsible for deploying, configuring, and sustaining digital manufacturing systems (e.g.,Manufacturing Execution Systems (MES), data historians, electronic logbooks) in a current good manufacturing practices (cGMP) environment. This role performs work of moderate scope with increasing independence, contributes to recipe-driven operations and electronic batch execution for drug substance manufacturing (DSM), and supports data and record integrity across integrated systems. This role partners cross-functionally (e.g., Manufacturing, Automation/IT, Quality) to translate process requirements into digital solutions, supports change control and validation activities, and leads small workstreams or continuous improvement initiatives to enhance reliability, compliance, and user experience. 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."

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https://www.fujifilm.com/us/en/about/region/careers Job Description What You'll Do Configures and sustains digital tools (MES, data historians, e-logbooks) in alignment with approved standards, master data, and recipe requirements; executes changes through documented change control Authors and maintainstechnical documentation (e.g., user requirements, configuration specifications, test scripts, SOPs, standard work) and supports review/approval workflows Executes and documents testing and validation activities (e.g., IQ/OQ/PQ, CSV) in accordance with cGMP, data integrity, and GAMP 5 principles Monitors system performance, conducts routine data analysis, and proactively addresses issues; performs first-level troubleshooting and root cause analysis of moderate complexity Supports electronic batch execution and manufacturing operations by ensuring digital readiness, masters data accuracy, and timely issue resolution Collaborates with Manufacturing, Quality, and Automation/IT to ensure solutions meet process needs, regulatory standards, and integration requirements (e.g., interfaces to

LIMS, ERP, DCS/PLC

) Prepares and delivers user training, job aids, and walkthroughs; provide day-to-day user support and may coach or guide junior team members on standard practices Contributes to audit readiness and participate in internal/external audits by preparing evidence and responding to observations Identifies and implements continuous improvement opportunities to streamline workflows, reduces errors, and improves system usability and performance; may lead small projects or workstreams Participates in rotational on-call support and after-hours activities during manufacturing campaigns, following escalation protocols Maintains accurate records, logs, and status updates; ensures timely completion of assigned tasks and adherence to schedules and priorities Other duties, as assigned Basic Requirements High School Diploma/GED with 4 years of related experience; or Associate's degree in Life Sciences or Engineering with 2 years of related experience; OR Bachelor's degree in Life Sciences, Engineering, Information Systems, or related field; OR Equivalent practical experience with no prior experience Preferred Requirements High School Diploma/GED with 6 years of related experience; OR Associate's degree in Life Sciences or Engineering with 4 years of related experience; OR Bachelor's degree in Life Sciences or Engineering with 2 years of related experience

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to discern audible cues Ability to stand for prolonged periods of time Ability to sit for prolonged periods of time Ability to operate machinery and/or power tools Ability to conduct work that includes moving objects up to 10 pounds Will work in outdoor elements such as precipitation and wind 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 (FDBN_PNC@fujifilm.com).