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

Fujifilm • Holly Springs, NC

2d

About The Position

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.

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

Nice To Haves

• 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees