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vTek Systems Inc

Manufacturing Engineer

vTek Systems Inc, Chicago, Illinois, United States, 60290

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Get AI-powered advice on this job and more exclusive features. Direct message the job poster from vTek Systems Inc We are seeking a skilled MES (Manufacturing Execution System) Engineer with strong experience in Rockwell PharmaSuite to support the design, configuration, implementation, and validation of MES solutions within a GMP-regulated pharmaceutical/biotech manufacturing environment. The individual will collaborate with cross-functional teams to ensure seamless integration of MES with automation, ERP, and lab systems, while ensuring compliance with FDA, EMA, and other regulatory standards. Key Responsibilities • Configure, customize, and deploy Rockwell PharmaSuite MES solutions to support batch execution, recipe management, and electronic batch records (EBR). • Work with manufacturing, QA, automation, and IT teams to capture user requirements and translate them into functional MES specifications. • Develop and maintain master batch records (MBRs), workflows, and equipment models within PharmaSuite. • Support MES integration with ERP (SAP), LIMS, DCS, and other systems. • Perform system validation activities including authoring URS, FRS, DS, IQ, OQ, PQ, and supporting CSV deliverables. • Troubleshoot MES issues and provide Level 2/3 support during production. • Participate in change control, deviation investigations, and CAPA management related to MES. • Ensure MES compliance with 21 CFR Part 11, Annex 11, GAMP 5, and data integrity standards. Seniority level

Seniority level Mid-Senior level Employment type

Employment type Contract Job function

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