Sr. Manufacturing Execution Systems Specialist

Position Overview

The Senior 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 Sr. MES Specialist 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, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're 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 we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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:

Job Description

What You'll Do

• Designs, configures, and maintains Master Batch Records (MBRs) 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 MBR performance and PAS-X functionality, and implement timely resolutions to maintain production continuity
• Identifies, quantifies, and drives continuous improvement opportunities that enhance electronic MBR design, reduce execution exceptions, minimize downtime, and improve right-first-time performance
• Leads and participates in change control processes, deviation investigations, and impact assessments relating to MES and electronic MBR updates
• Maintains alignment with regulatory compliance and quality standards in all electronic documentation and batch record configurations
• Mentors junior team members on PAS-X configuration practices, testing methods, and compliance expectations; review work products for quality and consistency
• Creates and maintains clear configuration documentation, workflow diagrams, and decision records to support audit readiness and knowledge transfer
• Other duties, as assigned

Basic Requirements

• High School Diploma or Equivalent with 12 years of applicable industry experience OR
• Bachelor's degree in Pharmaceutical Sciences, Biotechnology, Microbiology, or a related field with 8 years of applicable industry experience OR
• Master's degree with 4 years previous applicable industry experience
• Equivalent military experience or training
• Experience in drug product manufacturing, sterile processing, or quality assurance

Preferred Requirements

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
• 6+ years of experience in pharmaceutical manufacturing or MES systems (preferably PAS-X)

• Bioworks Certificate

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time

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 place. 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 committed to 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 ([email protected]).