Sr Digital Operations Specialist 1

Fujifilm•Holly Springs, NC

About The Position

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.

Requirements

High School Diploma or Equivalent with 12 years of applicable industry experience OR
Bachelor’s degree with 8 years of applicable industry experience OR
Master’s degree 6 years of applicable industry experience

Nice To Haves

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

Responsibilities

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 track 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