Manufacturing Execution System Specialist

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 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 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, reduce execution exceptions and downtime, and lower the frequency of quality deviations
• Participates in 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

• 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

• 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 M  design tools and libraries
• Bioworks certificate

• 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 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.

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 origin, disability, veteran status, etc.

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 ().