Digital Operations Specialist 2
FUJIFILM Biotechnologies, Holly Springs, NC, United States
The Digital Operations Specialist 2 independently deploys, configures, and sustains digital manufacturing systems (e.g., Manufacturing Execution Systems [MES], data historians, electronic logbooks) in a cGMP environment. This role leads work of diverse scope, translating manufacturing process requirements into robust digital solutions, owning configurations and master data for electronic batch execution, and ensuring data integrity across integrated systems. The Digital Operations Specialist 2 partners closely with Manufacturing, Automation/IT, and Quality to drive change control and validation activities, serves as a subject matter resource for complex troubleshooting, and leads small-to-medium projects or workstreams that improve reliability, compliance, and operational efficiency. This role owns the digital workstream for Tech Transfers, performing capability gap assessments between new customers or products, defining remediation plans, and ensuring digital readiness (recipes, master data, interfaces, training, procedures) for successful transfer.
Responsibilities
Leads configuration, enhancement, and sustainment of digital tools (e.g., MES, data historians, e-logbooks) in alignment with approved standards, master data, and recipe requirements; own changes through documented change control and ensure timely implementation
Authors, reviews, and maintains technical documentation (e.g., CMRs, URS, FS/DS, configuration specifications, test scripts, SOPs, standard work) and facilitate cross‑functional review and approval workflows
Plans, executes, and documents validation activities (e.g., IQ/OQ/PQ, CSV) consistent with cGMP, data integrity, and GAMP 5; provides input to risk assessments and validation strategies
Monitors system performance, analyzes data trends, and leads root cause investigations for issues of moderate to high complexity; implement corrective and preventive actions (CAPAs)
Ensures electronic batch readiness and master data accuracy; partners with operations to resolve execution issues and optimize recipe design and workflows
Coordinates and manages integrations with adjacent systems (e.g., LIMS, ERP, DCS/PLC, historians), including interface specifications, testing, and troubleshooting
Develops and delivers user training, job aids, and change communications; provides day‑to‑day user support and mentor junior team members on standards and best practices
Supports audit readiness; leads preparation of evidence, responds to observations, and drives remediation activities for internal/external inspections
Identifies, prioritizes, and leads continuous improvement initiatives that streamline digital workflows, reduce deviations/rework, and enhance system usability and performance
Plans and manages small‑to‑medium projects or workstreams, including scope, schedule, and stakeholder alignment; reports status and risks; ensures deliverables meet quality standards
Participates in rotational on‑call support and after‑hours activities during manufacturing campaigns, following 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 9 years of applicable industry experience OR
Associate’s degree with 7 years of applicable industry experience OR
Bachelor’s degree with 5 years of applicable industry experience OR
Master’s degree 3 years of applicable industry experience
Preferred Requirements
Bachelor's in Life Sciences, Engineering, Information Systems, or related discipline
Hands‑on experience with biopharma MES platforms (e.g., PAS‑X, Syncade) and data historians (e.g., OSIsoft/AVEVA PI), including recipe/master data ownership and validation
Working Conditions & Physical Requirements
Ability to discern audible cues
Ability to stand for prolonged periods of time
Ability to sit for prolonged periods of timeAbility 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 (FDBN_PNC@fujifilm.com).
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Responsibilities
Leads configuration, enhancement, and sustainment of digital tools (e.g., MES, data historians, e-logbooks) in alignment with approved standards, master data, and recipe requirements; own changes through documented change control and ensure timely implementation
Authors, reviews, and maintains technical documentation (e.g., CMRs, URS, FS/DS, configuration specifications, test scripts, SOPs, standard work) and facilitate cross‑functional review and approval workflows
Plans, executes, and documents validation activities (e.g., IQ/OQ/PQ, CSV) consistent with cGMP, data integrity, and GAMP 5; provides input to risk assessments and validation strategies
Monitors system performance, analyzes data trends, and leads root cause investigations for issues of moderate to high complexity; implement corrective and preventive actions (CAPAs)
Ensures electronic batch readiness and master data accuracy; partners with operations to resolve execution issues and optimize recipe design and workflows
Coordinates and manages integrations with adjacent systems (e.g., LIMS, ERP, DCS/PLC, historians), including interface specifications, testing, and troubleshooting
Develops and delivers user training, job aids, and change communications; provides day‑to‑day user support and mentor junior team members on standards and best practices
Supports audit readiness; leads preparation of evidence, responds to observations, and drives remediation activities for internal/external inspections
Identifies, prioritizes, and leads continuous improvement initiatives that streamline digital workflows, reduce deviations/rework, and enhance system usability and performance
Plans and manages small‑to‑medium projects or workstreams, including scope, schedule, and stakeholder alignment; reports status and risks; ensures deliverables meet quality standards
Participates in rotational on‑call support and after‑hours activities during manufacturing campaigns, following 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 9 years of applicable industry experience OR
Associate’s degree with 7 years of applicable industry experience OR
Bachelor’s degree with 5 years of applicable industry experience OR
Master’s degree 3 years of applicable industry experience
Preferred Requirements
Bachelor's in Life Sciences, Engineering, Information Systems, or related discipline
Hands‑on experience with biopharma MES platforms (e.g., PAS‑X, Syncade) and data historians (e.g., OSIsoft/AVEVA PI), including recipe/master data ownership and validation
Working Conditions & Physical Requirements
Ability to discern audible cues
Ability to stand for prolonged periods of time
Ability to sit for prolonged periods of timeAbility 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 (FDBN_PNC@fujifilm.com).
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