Sr. Manufacturing Execution Systems Specialist

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., * 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

• 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

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