MES / PAS-X MBR Designer

Avacone; Durham (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Avacone seeks an experienced MES / PAS-X MBR Designer to support Master Batch Record development at a pharmaceutical manufacturing site in Durham. This 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 include reviewing process documentation, performing fit-gap assessments, authoring and updating MBRs, and ensuring quality, data integrity, and governance across

Qualifications

• 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 with Business, Quality, Validation, and IT/OT stakeholders within 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; sponsorship not available for this position.

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.

Skills

GxP compliance

English communication

Tools

PAS-X v3.4

Job 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.

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.