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Position OverviewThe Sr. Digital Operations Specialist 1 leads the design, configuration, validation, and sustainment of digital manufacturing systems (e.g., MES, data historians, 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 and drives continuous improvement across integrated systems.This role leads the digital workstream for tech transfers-performing capability gap assessments for new clients and products, defining remediation plans, and ensuring digital readiness (e.g., recipes, master data, interfaces, training, standard operation procedures [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 operational efficiency.Company OverviewFUJIFILM 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/careersJob DescriptionWhat You'll DoLeads 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 governanceServes 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 domainAuthors, reviews, and approves technical documentation (e.g., URS, FS/DS, configuration specifications, test scripts, SOPs, standard work); facilitates cross-functional review and sign-offDefines 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 traceabilityMonitors system performance, analyzes trends, and leads root cause investigations for high-complexity issues; implements robust CAPAs and preventative measuresCoordinates and manages integrations with adjacent systems (e.g., LIMS, ERP, DCS/PLC, historians), including interface specifications, testing protocols, data mapping, and troubleshootingOwns 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 parameter models, interface requirements, reporting, security/roles, archival/retention Defines and tracks remediation plans (e.g., configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQMaps process parameters and data flows; aligns recipe design and material master data; authors/aligns URS and acceptance criteria for transfer-related changesCoordinates with external partners/CMOs to define interface needs, test data exchanges, and verify execution readiness; integrates milestones into project plans and stage-gate reviewsPrepares and delivers advanced user training, job aids, and change communications; provides day-to-day user support and mentor/coach junior team membersLeads audit readiness; prepares evidence, presents SME responses, and drives remediation for internal/external inspectionsIdentifies, prioritizes, and leads continuous improvement initiatives that streamline workflows, reduce deviations/rework, and enhance system usability and performance; quantifies benefits and track outcomesPlans and manages medium projects or multiple concurrent workstreams, including scope, schedule, budget awareness, risk management, and stakeholder alignment; provides regular status reportingParticipates in rotational on-call support and after-hours activities during manufacturing campaigns; leads incident triage and escalation protocolsMaintains accurate records, logs, and status updates; ensures adherence to schedules, priorities, and compliance requirementsOther duties, as assignedBasic RequirementsHigh School Diploma or Equivalent with 12 years of applicable industry experience ORBachelor's degree with 8 years of applicable industry experience ORMaster's degree 6 years of applicable industry experience Preferred RequirementsBachelors in Life Sciences, Engineering, Information Systems, or related disciplineSignificant experience configuring and supporting digital manufacturing systems in regulated environments (e.g., MES, PI/data historian, e-logbookWorking Conditions and Physical RequirementsAbility to discern audible cuesAbility to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to operate machinery and/or power toolsAbility to conduct work that includes moving objects up to 10 poundsWill work in outdoor elements such as precipitation and windTo 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 InformationFujifilm 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 InformationIf 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). Salary: . Date posted: 06/26/2026