Client is seeking an experienced PAS-X GMBR Developer / Designer to support a major Manufacturing Execution System (MES) initiative at a leading pharmaceutical manufacturing facility in Durham, NC. This individual will be responsible for the design, development, configuration, deployment, and ongoing support of Generic Master Batch Records (GMBRs) within the Werum PAS-X MES environment.

The ideal candidate will have hands-on experience developing electronic batch records, supporting GMP manufacturing operations, providing production support, and configuring MES-connected shop floor devices including printers, scales, scanners, and operator terminals.

 

• Design, develop, configure, test, and deploy Generic Master Batch Records (GMBRs) within the Werum PAS-X MES platform.

• Translate manufacturing process requirements into PAS-X electronic batch record solutions.

• Collaborate with Manufacturing, MS&T, QA, Validation, Automation, and IT teams to gather requirements and implement MES solutions.

• Configure workflows, process instructions, data collection forms, and exception handling within PAS-X.

• Provide day-to-day production support for the PAS-X MES environment, including troubleshooting batch execution issues and resolving manufacturing system incidents.

• Support manufacturing operations during batch execution and work directly with end users to resolve MES-related issues.

• Configure and support PAS-X interfaces with printers, barcode scanners, weigh scales, terminals, and other shop floor devices.

• Troubleshoot hardware, connectivity, and communication issues involving MES-integrated equipment and peripherals.

• Support integration between PAS-X, automation systems, manufacturing equipment, and other site applications.

• Troubleshoot, optimize, and enhance existing batch records and MES workflows.

• Author and review functional specifications, configuration documents, and technical documentation.

• Support validation activities including IQ/OQ/PQ, UAT, and system testing.

• Participate in deviation investigations, root cause analysis, CAPAs, and change control activities.

• Ensure compliance with GMP regulations, GAMP 5 guidelines, ALCOA+ principles, and 21 CFR Part 11 requirements.

• Support system deployments, go-live activities, and post-implementation stabilization efforts.

 

• 5+ years of experience supporting Werum PAS-X MES in a pharmaceutical or biotechnology environment.

• Proven experience developing and configuring GMBRs/electronic batch records within PAS-X.

• Hands-on experience providing production support in a live manufacturing environment.

• Experience configuring and supporting printers, barcode scanners, weigh scales, terminals, and other MES-connected shop floor devices.

• Strong understanding of pharmaceutical or biotechnology manufacturing processes.

• Experience working in GMP-regulated environments.

• Working knowledge of computerized system validation (CSV) and system lifecycle requirements.

• Familiarity with GAMP 5, data integrity requirements, and 21 CFR Part 11.

• Experience supporting MES integrations with manufacturing equipment and site systems.

• Strong troubleshooting, documentation, communication, and problem-solving skills.

• Ability to work effectively in a cross-functional project environment.

 

• Experience supporting PAS-X implementations, upgrades, or site expansions.

• Experience with PAS-X V3 and/or PAS-X 3.3.

• Familiarity with SAP, DeltaV, PI Historian, LIMS, or other manufacturing systems.

• Experience supporting biologics, vaccines, sterile manufacturing, or large-scale pharmaceutical operations.

• Experience integrating legacy manufacturing equipment with PAS-X.

• Previous experience supporting MES systems on the manufacturing floor during commercial production