6287 - MES CSV Engineer / Validation Engineer

Verista, Inc.•Indianapolis, IN

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise 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

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