A Pharmaceutical Manufacturing Process Engineer designs and maintains manufacturing equipment, facilities and processes for a pharmaceutical company. Maintains process controls for the specific sterile processing requirements of pharmaceutical manufacturing.
Designer Avacone Durham, NC Job Details Full-time 15 hours ago Qualifications Data integrity assurance Document control experience within pharmaceutical industry Gap analysis English GMP Pharmaceutical company experience Batch records Cross-functional collaboration Pharmaceutical manufacturing facility experience Stakeholder management Full 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. 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.
