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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr. Manufacturing Execution Systems Specialist - **Company:** Fujifilm Holdings America Corporation - **Location:** Holly Springs, NC, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Data Integrity, Electronic Signatures, System Testing, User-Centered Design, Workflow Management Systems, Electronic Filing System, Information Technology - **Published:** May 21, 2026 - **Apply:** https://www.juju.com/job/00000000g18qgq ## About the Role * 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 ## Description 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 ## Related Videos - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [Design as an algorithm, not as a feature](https://www.wearedevelopers.com/videos/471-design-as-an-algorithm-not-as-a-feature) - [How To Test A Ball of Mud](https://www.wearedevelopers.com/videos/173-how-to-test-a-ball-of-mud) - [The Billion Dollar Machine: First Time Right.](https://www.wearedevelopers.com/videos/393-the-billion-dollar-machine-first-time-right) - [Insight into AI-Driven Design](https://www.wearedevelopers.com/videos/1016-insight-into-ai-driven-design) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [System change: restart as developer?](https://www.wearedevelopers.com/magazine/39-system-change-restart-as-developer) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023) - [Starter Kit For Job Applications For Developers](https://www.wearedevelopers.com/magazine/7-starter-kit-for-job-applications-for-developers)