0043V6287 MES Validation Engineer/Validation Engineer Consultant
About The Position
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
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
Nice To Haves
- Expertise with MES modules; experience with L7 MES Module is a plus
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
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What This Job Offers
Career Level
Mid Level
