Job Information
Fujifilm Sr Digital Operations Specialist 1 in Holly Springs, North Carolina
Position Overview
The Sr. Digital Operations Specialist 1 leads the design, configuration, validation, and sustainment of digital manufacturing systems (e.g., MES, datahistorians, electronic logbooks) in a cGMP environment. This role acts as the subject matter expert (SME) for one unit operation family (Upstream,Downstream, or Solutions). The Sr. Digital Operations Specialist 1 owns recipe and master data governance for electronic batch record (EBR) execution anddrives continuous improvement across integrated systems. This role leads the digital workstream for tech transfers—performing capability gap assessmentsfor new clients and products, defining remediation plans, and ensuring digital readiness (e.g., recipes, master data, interfaces, training, standard operationprocedures [SOPs], change controls) for successful transfer. This role operates with substantial independence, influences cross-functional decisions (e.g.,Manufacturing, Automation/IT, Quality, Supply Chain), and leads projects/workstreams that materially improve reliability, compliance, and operationalefficiency.
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
• Leads complex configuration, enhancement, and sustainment of digital tools (e.g., MES, data historians, e-logbooks) aligned to approved standards,
recipe design, and master data; owns changes through documented change control and governance
• Serves as unit operations SME (e.g., Upstream, Downstream, or Solutions); owns recipe design standards, parameter models, equipment models,material master data, and EBR usability within the assigned domain
• Authors, reviews, and approves technical documentation (e.g., URS, FS/DS, configuration specifications, test scripts, SOPs, standard work);facilitates cross-functional review and sign-off
• Defines validation strategies and executes CSV activities (IQ/OQ/PQ) using risk-based approaches consistent with cGMP, ALCOA+, and GAMP 5;contribute to risk assessments and traceability
• Monitors system performance, analyzes trends, and leads root cause investigations for high-complexity issues; implements robust CAPAs andpreventative measures
• Coordinates and manages integrations with adjacent systems (e.g., LIMS, ERP, DCS/PLC, historians), including interface specifications, testingprotocols, data mapping, and troubleshooting
• Owns technology transfer digital readiness and capability gap assessments for new clients/products:
Conducts structured gap analyses between sending and receiving sites for MES objects/recipes, master data, equipment and parametermodels, interface requirements, reporting, security/roles, archival/retention
Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior toengineering/PQ runs and PPQ
Maps process parameters and data flows; aligns recipe design and material master data; authors/aligns URS and acceptance criteria fortransfer-related changes
Coordinates with external partners/CMOs to define interface needs, test data exchanges, and verify execution readiness; integratesmilestones into project plans and stage-gate reviews
• Prepares and delivers advanced user training, job aids, and change communications; provides day-to-day user support and mentor/coach juniorteam members
• Leads audit readiness; prepares evidence, presents SME responses, and drives remediation for internal/external inspections
• Identifies, prioritizes, and leads continuous improvement initiatives that streamline workflows, reduce deviations/rework, and enhance systemusability and performance; quantifies benefits and track outcomes
• Plans and manages medium projects or multiple concurrent workstreams, including scope, schedule, budget awareness, risk management, andstakeholder alignment; provides regular status reporting
• Participates in rotational on-call support and after-hours activities during manufacturing campaigns; leads incident triage and escalation protocols
• Maintains accurate records, logs, and status updates; ensures adherence to schedules, priorities, and compliance requirements
• Other duties, as assigned
Basic Requirements
• High School Diploma or Equivalent with 12 years of applicableindustry experience OR
• Bachelor’s degree with 8 years of applicable industry experience OR
• Master’s degree 6 years of applicable industry experience
Preferred Requirements
• Bachelors in Life Sciences, Engineering, Information Systems, orrelated discipline
• Significant experience configuring and supporting digitalmanufacturing systems in regulated environments (e.g., MES, PI/datahistorian, e-logbook
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).
Job Locations US-NC-Holly Springs
Posted Date 4 days ago (4/17/2026 8:25 AM)
Requisition ID 2026-37572
Category Manufacturing
Company (Portal Searching) FUJIFILM Biotechnologies