Manufacturing Execution System Specialist 1

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

The Manufacturing Execution System (MES) Specialist owns the end-to-end design configuration testing and lifecycle support of electronic Master Batch Records (eMBRs) within PAS-X. This role ensures eMBRs align with manufacturing process requirements cGMP/regulatory standards and digital integration objectives driving continuous improvement and compliance. The MES Specialist 1 scopes work sets priorities and delivers solutions for electronic batch execution in drug product manufacturing engaging cross-functional stakeholders only as needed to meet timelines and quality standards.

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

Designs configures and maintains Master Batch Records in PAS-X based on defined manufacturing processes and regulatory requirements
Executes and documents system testing and computer system validation activities to confirm compliance with 21 Code of Federal Regulations Part 11 European Union Annex 11 and applicable data integrity expectations
Defines and manages key batch components in the system including materials equipment parameter sets interlocks and electronic signatures and workflow logic to ensure accurate and reliable execution
Collaborates with Manufacturing Quality Assurance Process Engineering Validation and Information Technology to gather user requirements and translates into functional digital workflows and acceptance criteria
Provides on-floor support during batch execution troubleshoot issues related to electronic Master Batch Record performance and PAS-X functionality and implement timely resolutions to maintain production continuity
Drives continuous improvement initiatives that enhance electronic Master Batch Record design reduces execution exceptions and downtime and lowers the frequency of quality deviations
Participates and leads change control processes deviation investigations and impact assessments relating to Manufacturing Execution System and electronic Master Batch Records updates
Maintains alignment with regulatory compliance and quality standards in all electronic documentation and batch record configurations
Other duties as assigned

Basic Requirements

High School Diploma or Equivalent with 6 years of applicable industry experience OR
Bachelors degree in Pharmaceutical Sciences Biotechnology Microbiology or a related field with 2 years of applicable industry experience OR
Masters degree with no previous experience
Equivalent military experience or training
Experience in drug product manufacturing sterile processing or quality assurance

Preferred Requirements

Bachelors degree in Engineering Computer Science Life Sciences or related field
2 years of experience in pharmaceutical manufacturing or MES systems (preferably PAS-X)
Strong understanding of drug product processes (formulation filling lyophilization inspection packaging)
Proficiency in PAS-X MBR design tools and libraries

Bioworks certificate

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to stand for prolonged periods of time.
Ability to sit for prolonged periods of time.
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers.

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 Manufacturing Execution System (MES) Specialist owns the end-to-end design configuration testing and lifecycle support of electronic Master Batch Records (eMBRs) within PAS-X. This role ensures eMBRs align with manufacturing process requirements cGMP/regulatory standards and dig...