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 roleperforms 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.” Visit: 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 machiner