MES SME — Pharma GMP & Digital Manufacturing

Pinnaql, Inc.; Wilson (NC); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Validation & Engineering Group in the United States seeks a Manufacturing Execution Systems (MES) Subject Matter Expert to support pharmaceutical manufacturing operations and digital initiatives. You will lead MES configuration, integration with PAS-X, DeltaV and SAP, and ensure compliant system performance across engineering, quality, IT/OT, and validation teams.

The role emphasizes lifecycle management, troubleshooting, and creating documentation for GMP-compliant MES solutions in a regulated

Qualifikationen

• 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.
• Strong troubleshooting, communication, and cross-functional collaboration skills.
• Experience integrating MES, automation, and enterprise systems in complex pharmaceutical manufacturing environments is highly preferred.

Aufgaben

• 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.

Jobbeschreibung

Validation & Engineering Group in the United States seeks a Manufacturing Execution Systems (MES) Subject Matter Expert to support pharmaceutical manufacturing operations and digital initiatives. You will lead MES configuration, integration with PAS-X, DeltaV and SAP, and ensure compliant system performance across engineering, quality, IT/OT, and validation teams.

The role emphasizes lifecycle management, troubleshooting, and creating documentation for GMP-compliant MES solutions in a regulated