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.