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MES / PAS-X MBR Designer

Avacone · Durham, États-Unis d'Amérique · On-site

  • Bureau à Durham
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Description

We are seeking an experienced MES / PAS-X MBR Designer to support Master Batch Record development at a pharmaceutical manufacturing site in Durham. The role focuses on designing, configuring, and maintaining MBRs in PAS-X v3.4, aligned with the Global MES Template and site-specific manufacturing requirements.

Key Responsibilities

  • Review and assess process documentation, batch records, manufacturing instructions, and other source materials required for MBR design.
  • Perform fit-gap assessments against the Global MES Template, global design standards, and approved library elements, identifying justified local adaptations.
  • Author, configure, update, and maintain MBRs in PAS-X v3.4 using approved templates, libraries, naming conventions, and design principles.
  • Incorporate product- and process-specific materials, quantities, parameters, instructions, calculations, checks, and in-process controls based on approved documentation.
  • Perform design quality, consistency, and system integrity checks and resolve issues before formal review and approval.
  • Support MBR review cycles, coordinate reviews, resolve comments, and incorporate approved feedback from Business, Quality, Validation, and IT/OT stakeholders.
  • Prepare and maintain design documentation, version histories, and traceability records.
  • Support design verification and deployment readiness through design reviews, dry runs, test preparation, and defect resolution.
  • Comply with applicable quality, GxP, data integrity, documentation, and information security requirements.

Requirements

Required Qualifications and Experience

  • Demonstrable hands-on experience in PAS-X / MES MBR design within regulated pharmaceutical manufacturing.
  • Strong expertise in Master Batch Record authoring and configuration, including experience with PAS-X v3.4.
  • Experience with template-based MES design, reusable library elements, and fit-gap assessments.
  • Sound understanding of pharmaceutical manufacturing processes, GxP requirements, data integrity, and controlled documentation.
  • Ability to collaborate effectively with Business, Quality, Validation, and IT/OT stakeholders within established governance and project delivery frameworks.
  • Strong English communication and documentation skills.
  • Availability to work onsite in Durham, USA.
  • Authorization to work in the United States without employer sponsorship, now or in the future. Sponsorship is not available for this position.


Preferred Experience

  • Previous experience with the Novartis Global MES Template and Novartis project delivery standards.