Onsite PAS-X MBR Designer for Pharma MES

Avacone; North Carolina; On-site; USD 110,000 - 140,000; Full time

Job summary

Avacone is 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.

The candidate will review process documentation, perform fit-gap assessments, author and configure MBRs, and ensure compliance with GxP and data integrity.

Qualifications

• Hands-on PAS-X/MES MBR design experience in regulated pharma manufacturing.
• Strong Master Batch Record authoring and configuration skills, including PAS-X v3.4.
• Experience with template-based MES design and reusable library elements.
• Solid understanding of GMP, data integrity, and controlled documentation.

Responsibilities

• Review process documentation and source materials for MBR design.
• Perform fit-gap assessments against Global MES Template and approved libraries.
• Author, configure, and maintain MBRs in PAS-X v3.4 using approved templates.
• Incorporate materials, quantities, parameters, and in-process controls per documentation.
• Conduct design quality checks and resolve issues before review/approval.
• Coordinate MBR reviews and incorporate feedback from stakeholders.
• Prepare design documentation, version histories, and traceability records.
• Support design verification and deployment readiness through reviews and testing.
• Comply with quality, GxP, data integrity, and information security requirements.

Skills

PAS-X/MES MBR design

Master Batch Record authoring

Template-based MES design

Data integrity & GMP

Cross-functional collaboration

English documentation

Tools

PAS-X v3.4

Job description

Avacone is 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.

The candidate will review process documentation, perform fit-gap assessments, author and configure MBRs, and ensure compliance with GxP and data integrity.