Digital Operations AssociateDigital Operations Specialist 12 (Experience Based)

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

The Digital Operations Specialist 1 is an early-career professional responsible for deploying configuring and sustaining digital manufacturing systems (e.g.Manufacturing Execution Systems (MES) data historians electronic logbooks) in a current good manufacturing practices (cGMP) environment. This role
performs work of moderate scope with increasing independence contributes to recipe-driven operations and electronic batch execution for drug substance manufacturing (DSM) and supports data and record integrity across integrated systems. This role partners cross-functionally (e.g. Manufacturing Automation/IT Quality) to translate process requirements into digital solutions supports change control and validation activities and leads small workstreams or continuous improvement initiatives to enhance reliability compliance and user experience.

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

Configures and sustains digital tools (MES data historians e-logbooks) in alignment with approved standards master data and recipe requirements; executes changes through documented change control
Authors and maintainstechnical documentation (e.g. user requirements configuration specifications test scripts SOPs standard work) and supports review/approval workflows
Executes and documents testing and validation activities (e.g. IQ/OQ/PQ CSV) in accordance with cGMP data integrity and GAMP 5 principles
Monitors system performance conducts routine data analysis and proactively addresses issues; performs first-level troubleshooting and root cause analysis of moderate complexity
Supports electronic batch execution and manufacturing operations by ensuring digital readiness masters data accuracy and timely issue resolution
Collaborates with Manufacturing Quality and Automation/IT to ensure solutions meet process needs regulatory standards and integration requirements (e.g. interfaces to LIMS ERP DCS/PLC)
Prepares and delivers user training job aids and walkthroughs; provide day-to-day user support and may coach or guide junior team members on standard practices
Contributes to audit readiness and participate in internal/external audits by preparing evidence and responding to observations
Identifies and implements continuous improvement opportunities to streamline workflows reduces errors and improves system usability and performance; may lead small projects or workstreams
Participates in rotational on-call support and after-hours activities during manufacturing campaigns following escalation protocols
Maintains accurate records logs and status updates; ensures timely completion of assigned tasks and adherence to schedules and priorities
Other duties as assigned

Basic Requirements

High School Diploma/GED with 4 years of related experience; or
Associates degree in Life Sciences or Engineering with 2 years of related experience; OR
Bachelors degree in Life Sciences Engineering Information Systems or related field; OR
Equivalent practical experience with no prior experience

Preferred Requirements

High School Diploma/GED with 6 years of related experience; OR
Associates degree in Life Sciences or Engineering with 4 years of related experience; OR
Bachelors degree in Life Sciences or Engineering with 2 years of related experience

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 1 is an early-career professional responsible for deploying configuring and sustaining digital manufacturing systems (e.g.Manufacturing Execution Systems (MES) data historians electronic logbooks) in a current good manufacturing practices (cGMP) env...