MES SME: GMP Systems Expert (PAS-X, SAP, DeltaV)

Pinnaql; North Carolina; On-site; USD 120,000 - 160,000; Full time

Job summary

Validation & Engineering Group is hiring a Manufacturing Execution Systems (MES) Subject Matter Expert to support pharmaceutical and regulated manufacturing environments. You will lead MES configuration, troubleshoot integrations, and coordinate with cross-functional teams to ensure compliant system performance and lifecycle management.

The role focuses on PAS-X, DeltaV, and SAP integrations, with responsibilities spanning validation, data integrity, and technical documentation.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Automation, Information Systems, or a related technical discipline.
• Demonstrated experience supporting MES in pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience with Emerson DeltaV and SAP integrations in a manufacturing environment.
• Strong understanding of electronic batch records, manufacturing workflows, automation integration, and production systems.
• Experience supporting GMP computerized systems, commissioning/qualification, validation, change control, deviations, and system lifecycle activities.

Responsibilities

• Serve as the MES Subject Matter Expert supporting manufacturing operations and digital manufacturing initiatives.
• Provide technical leadership for MES configuration, implementation, optimization, troubleshooting, and lifecycle support.
• Support integration and data flow between PAS-X, DeltaV, SAP, and associated manufacturing systems.
• Partner with Manufacturing, Automation, Engineering, Quality, IT/OT, and Validation teams to ensure reliable and compliant system performance.
• Support electronic batch records, master batch record configuration, manufacturing workflows, recipes, and system interfaces.
• Lead or support system changes, upgrades, testing, commissioning, qualification, and validation activities.
• Troubleshoot complex MES and system-integration issues and drive root-cause resolution.
• Ensure solutions comply with GMP, data integrity, computerized system validation, and applicable regulatory requirements.
• Develop and maintain technical documentation, procedures, specifications, and system lifecycle documentation.
• Provide technical guidance and mentorship to project and site teams.

Job description

Validation & Engineering Group is hiring a Manufacturing Execution Systems (MES) Subject Matter Expert to support pharmaceutical and regulated manufacturing environments. You will lead MES configuration, troubleshoot integrations, and coordinate with cross-functional teams to ensure compliant system performance and lifecycle management.

The role focuses on PAS-X, DeltaV, and SAP integrations, with responsibilities spanning validation, data integrity, and technical documentation.