Sr Digital Operations Specialist 1

Position Overview The 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 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. 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 and preventative measures. Coordinates and manages integrations with adjacent systems (e.g., LIMS, ERP, DCS/PLC, historians), including interface specifications, testing protocols, 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 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 PPQ. Maps process parameters and data flows; aligns recipe design and material master data; authors/aligns URS and acceptance criteria for transfer‑related changes. Coordinates with external partners/CMOs to define interface needs, test data exchanges, and verify execution readiness; integrates milestones 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 junior team 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 system usability and performance; quantifies benefits and tracks outcomes. Plans and manages medium projects or multiple concurrent workstreams, including scope, schedule, budget awareness, risk management, and stakeholder 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 applicable industry experience. Bachelor’s degree with 8 years of applicable industry experience. Master’s degree 6 years of applicable industry experience. Preferred Requirements Bachelors in Life Sciences, Engineering, Information Systems, or related discipline. Significant experience configuring and supporting digital manufacturing systems in regulated environments (e.g., MES, PI/data historian, 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. 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 (View email address on click.appcast.io). #J-18808-Ljbffr Merck & Co.