MES Specialist
Technical Source is currently supporting a global pharmaceutical manufacturer in Wilson, NC with a critical MES Specialist need. This role will support a live PAS-X migration and act as the on-site MES point person until a full-time Lead is hired.
This position sits at the intersection of Operations, Quality, and Automation. The ideal candidate has hands-on experience with PAS-X configuration, electronic batch records (EBR), and GMP manufacturing environments.
This is a high-visibility role supporting batch execution, system troubleshooting, migration validation, and interface coordination.
Key Responsibilities:
Operational MES Support
- Serve as primary MES support contact for manufacturing operations
- Troubleshoot batch execution issues, workflow errors, and system connectivity problems
- Support scanner, printer, and interface-related troubleshooting
- Review audit trails and resolve production system issues in real time
- Provide guidance to operators on MES workflows and compliance requirements
PAS-X Migration & Interface Coordination
- Support recipe and Master Batch Record (MBR) migration from legacy system into PAS-X
- Partner with external migration team to validate configuration and data integrity
- Execute and support interface testing between MES, ERP, LIMS, and automation systems
- Document and track defects during testing and cutover activities
FAT / SAT & System Testing
- Participate in Factory Acceptance Testing (FAT) sessions
- Execute validation test scripts and confirm system functionality
- Review MES configuration to ensure alignment with GMP and operational requirements
- Support go-live stabilization activities
Global Alignment & Continuous Improvement
- Interface with global MES governance team to align site standards
- Identify workflow improvements to enhance usability and compliance
- Partner with future MES Lead to implement system optimizations
Required Qualifications
- 8+ years of experience supporting Manufacturing Execution Systems (MES)
- Hands-on experience with Werum PAS-X (configuration or support level)
- Experience supporting electronic batch records (EBR) in GMP environments
- Strong understanding of audit trails, electronic signatures, and data integrity
- Experience participating in system migrations, FAT/SAT, or go-live activities
- Ability to troubleshoot MES-related issues across operations, IT, and automation teams
- Comfortable working onsite in a manufacturing environment
Preferred Qualifications
- Experience in biopharmaceutical or sterile manufacturing
- Interface experience with ERP (SAP), LIMS, or DeltaV systems
- Understanding of 21 CFR Part 11 requirements
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