Digital Operations Specialist 2

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 9 days ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

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.

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 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
Associates degree with 7 years of applicable industry experience OR
Bachelors degree with 5 years of applicable industry experience OR

Masters degree 3 years of applicable industry experience

Preferred Requirements

Bachelors 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 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:

Position OverviewThe 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 proce...