Manufacturing Execution System Specialist 1

Fujifilm • Holly Springs, NC

1d

About The Position

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, 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: https://www.fujifilm.com/us/en/about/region/careers Job Description What You’ll Do

Requirements

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

Nice To Haves

• Bachelor’s 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 501-1,000 employees