0043V6287 MES Validation Engineer/Validation Engineer Consultant

Company : Two River Consulting Partners

Job Type : Contract

Indianapolis, In

Job Description - 0043V6287 MES Validation Engineer/Validation Engineer Consultant

0043V6287 MES Validation Engineer/Validation Engineer Consultant
Please contact Amanda Mazza, [email protected]

MES CSV Engineer Job Responsibilities:

Develop, configure, and revise MES recipes to support manufacturing operations, ensuring accuracy, efficiency, and compliance with GMP standards
Drive recipe optimization initiatives, including error correction and process improvements, with minimal supervision
Support Computer System Validation (CSV) activities including documentation, testing, and lifecycle management of MES systems
Collaborate cross-functionally with Manufacturing, Quality, IT, and Engineering teams to ensure system functionality aligns with product and process requirements
Participate in deviation investigations, change controls, and continuous improvement efforts related to MES and recipe management
Ensure all MES activities are audit-ready and compliant with regulatory requirements for Phase 3 and commercial manufacturing environments

Job Requirements:

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
3+ years of experience in MES, CSV, or automation within a GMP-regulated industry (pharmaceutical, biotech, or life sciences)
Hands-on experience with MES recipe authoring and lifecycle management
Experience working in Phase 3 and/or commercial manufacturing environments
Expertise with MES modules; experience with L7 MES Module is a plus
Strong understanding of CSV principles, GxP compliance, and data integrity requirements
Ability to work independently and collaboratively within cross-functional teams
Strong problem-solving skills with the ability to drive solutions with limited direction

LOCATION
Indianapolis, IN

EMPLOYMENT
C2C or W2

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0043V6287 MES Validation Engineer/Validation Engineer Consultant

Job Description - 0043V6287 MES Validation Engineer/Validation Engineer Consultant

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