What are the responsibilities and job description for the 0043V6287 MES Validation Engineer/Validation Engineer Consultant position at Two River Consulting Partners?
0043V6287 MES Validation Engineer/Validation Engineer Consultant
Please contact Amanda Mazza, amanda@tworivercp.comMES CSV Engineer Job Responsibilities{{:}}
Indianapolis, IN
EMPLOYMENT
C2C or W2
Please contact Amanda Mazza, amanda@tworivercp.comMES 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
- 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
Indianapolis, IN
EMPLOYMENT
C2C or W2