# MES / PAS-X MBR Designer

**Company:** [Avacone](null/companies/kvak1oQzkZ4HB1vYKYku9o.md)
**Location:** Durham, United States
**Workplace:** on site
**Employment type:** Full-time
**Department:** USA

[Apply for this job](null/view/28a43723-40e5-4599-8d47-d0e782cb00b2)

## 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.