MES Validation Engineer

Job Summary

Supporting the multi-phase deployment of Manufacturing Execution Systems (MES), the full-time MES Validation Engineer will focus on Computerized System Validation (CSV) activities in a GMP-regulated environment, ensuring compliance with industry standards while working remotely.

Key responsibilities:

• Develop, author, execute, and route validation deliverables, including test scripts and protocols, ensuring compliance with FDA, EMA, and GxP standards
• Collaborate with IT/OT teams and business process owners to align validation strategies with project objectives and existing validated GMP systems
• Provide subject matter expertise on validation approaches and risk assessments throughout MES deployment activities

Required qualifications:

• 5 years of experience in validation with a focus on computerized systems
• Bachelor's degree in Biomedical Engineering, Regulatory Affairs, or a related life sciences discipline
• Experience with Rockwell FactoryTalk PharmaSuite
• Knowledge of Computerized System Validation (CSV) principles and regulatory requirements
• Experience executing validation activities in GMP-regulated environments