The Role
Designs, configures, updates, and maintains Master Batch Records in PAS-X v3.4 for regulated pharmaceutical manufacturing. Reviews source documentation, performs fit-gap assessments against global templates, incorporates process requirements, and conducts quality and system integrity checks. Coordinates review cycles with Business, Quality, Validation, and IT/OT stakeholders, maintains traceability documentation, and supports design verification, dry runs, testing, deployment readiness, and defect resolution while complying with GxP and data integrity requirements.
Summary Generated by Built In
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.
Skills Required
- Hands-on PAS-X or MES Master Batch Record design experience in regulated pharmaceutical manufacturing
- Expertise in Master Batch Record authoring and configuration using PAS-X v3.4
- Experience with template-based MES design, reusable library elements, and fit-gap assessments
- 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 now or in the future
- Previous experience with the Novartis Global MES Template and Novartis project delivery standards
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The Company
What We Do
Avacone is a Swiss-based service provider specializing in IT infrastructure and pharmaceutical engineering, delivering specialized solutions for regulated and non-regulated environments in the pharmaceutical, chemical, and medical technology sectors.
