Sr Digital Operations Specialist 1

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

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 transfersperforming 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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll 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 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

Basic Requirements

High School Diploma or Equivalent with 12 years of applicable industry experience OR
Bachelors degree with 8 years of applicable industry experienceOR
Masters 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 and 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

To 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 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 Information

Fujifilm is committedto 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 ().

Required Experience:

Senior IC

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 (U...