MES Validation Engineer

Role Overview

• Develop, draft, and route validation protocols, test scripts, and reports
• Execute computer system validation (CSV) in a GMP-regulated environment.
• Support MES deployment , including validation strategy and testing.
• Collaborate with IT/OT, quality, and business teams.
• Ensure systems meet FDA, EMA, and GxP regulatory standards.

Requirements

• 5+ years of validation or CSV experience
• Experience in GMP or regulated pharma/biotech environments
• Hands-on experience with MES systems
• Experience developing and executing validation protocols and test scripts
• Strong knowledge of FDA, GxP, and system validation standards
• Bachelor’s degree in a life sciences or technical field.

Benefits

• Medical
• Dental
• Vision
• Paid Sick leave
• 401K