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Manufacturing Execution System (MES) Specialist 1

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 3 June 2026 (30+ days ago)

Application Deadline: 30 September 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

Own the end-to-end design configuration testing and lifecycle support of electronic Master Batch Records (eMBRs) in Werum PAS-X. As an MES Specialist I you will translate manufacturing science into digital workflows that power our drug product operationsdriving right-first-time execution data integrity and compliant performance in a dynamic 24/7 environment.

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

Support operational readiness during project phases including site commissioning and qualification efforts.
Act as a process subject matter expert (SME) to troubleshoot and resolve issues across assigned process areas.
Coordinate Batch Planning including process template creation/import and Preventive Maintenance (PM) management.
Own and drive major documentation updates; initiate new documents to support new processes.
Coordinate non-batch activities such as changeovers PMs and Aseptic Process Simulations (APS).
Partner with MSAT to support technology transfer into manufacturing.
Champion compliance and safety ensuring procedures are followed in the manufacturing environment.
Create and update Electronic Batch Records (EBRs/eMBRs) in PAS-X and support Paper Batch Records as needed.
Manage perform initiate or support quality system records including change controls investigations CAPAs and Continuous Improvement (CI) activities.
Lead and participate in projects within Drug Product Finished Goods; manage execution to plan.
Support internal and external inspections and audits to maintain a state of compliance.
Assist the Manager with projects training onboarding and knowledge transfer.
Perform other duties as needed to meet production and compliance goals.

Note: This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.

Minimum education and experience requirements

High School Diploma or equivalent with 9 years of applicable industry experience; OR
Bachelors degree with 5 years of applicable industry experience; OR
Masters degree with 3 years of applicable industry experience; OR
PhD with no prior industry experience; OR
Equivalent Military Experience
High degree of understanding of operations sequence and the cadence of activities in a manufacturing environment

Minimum training/certifications: N/A

Preferred education and experience

BioWorks or BTEC Capstone cGMP coursework preferred

What youll bring

Strong verbal and written communication skills; ability to effectively present information.
Strong time management; able to prioritize and deliver in a fast-paced setting.
Critical thinking and superior problem-solving skills.
Ability to analyze and troubleshoot simple to moderate system and component issues.
Ability to coordinate and facilitate effective small cross-functional teams.
Mentorship mindset with the ability to guide junior associates.
Team-based attitude; able to build relationships and work effectively in a global cross-functional environment.

Ready to help transform how medicines are madeand make a measurable impact on patient outcomes Apply today.

Equal opportunity We are an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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:

IC

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About Company

Fujifilm

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