Sr Digital Operations Specialist 1

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. Responsibilities Lead complex configuration, enhancement, and sustainment of digital tools (e.g., MES, data historians, e‑logbooks) aligned to approved standards, recipe design, and master data; own changes through documented change control and governance. Serve as unit operations SME (e.g., Upstream, Downstream, or Solutions) and own recipe design standards, parameter models, equipment models, material master data, and EBR usability within the assigned domain. Author, review, and approve technical documentation (e.g., URS, FS/DS, configuration specifications, test scripts, SOPs, standard work); facilitate cross‑functional review and sign‑off. Define validation strategies and execute CSV activities (IQ/OQ/PQ) using risk‑based approaches consistent with cGMP, ALCOA+, and GAMP 5; contribute to risk assessments and traceability. Monitor system performance, analyze trends, and lead root‑cause investigations for high‑complexity issues; implement robust CAPAs and preventative measures. Coordinate and manage integrations with adjacent systems (e.g., LIMS, ERP, DCS/PLC, historians), including interface specifications, testing protocols, data mapping, and troubleshooting. Own technology‑transfer digital readiness and capability‑gap assessments for new clients/products; conduct 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; define and track remediation plans (configuration, validation, training, SOPs, change controls) to close gaps prior to engineering/PQ runs and PPQ; map process parameters and data flows; align recipe design and material master data; author/align URS and acceptance criteria for transfer‑related changes; coordinate with external partners/CMOs to define interface needs, test data exchanges, and verify execution readiness; integrate milestones into project plans and stage‑gate reviews. Prepare and deliver advanced user training, job aids, and change communications; provide day‑to‑day user support and mentor/coach junior team members. Lead audit readiness; prepare evidence, present SME responses, and drive remediation for internal/external inspections. Identify, prioritize, and lead continuous improvement initiatives that streamline workflows, reduce deviations/rework, and enhance system usability and performance; quantify benefits and track outcomes. Plan and manage medium projects or multiple concurrent workstreams, including scope, schedule, budget awareness, risk management, and stakeholder alignment; provide regular status reporting. Participate in rotational on‑call support and after‑hours activities during manufacturing campaigns; lead incident triage and escalation protocols. Maintain accurate records, logs, and status updates; ensure 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 with 6 years of applicable industry experience. Preferred Requirements Bachelor’s 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 Statement 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 FUJIFILM Biotechnologies