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0043V6287 MES Validation Engineer/Validation Engineer Consultant

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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

 
Original job 0043V6287 MES Validation Engineer/Validation Engineer Consultant posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
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