MES Validation Engineer

Job Summary

Supporting the deployment and validation of Manufacturing Execution Systems (MES) in a 100% remote contract role, the MES Validation Engineer will ensure compliance and operational readiness within a GMP-regulated environment by developing validation protocols and collaborating with cross-functional teams.

Key responsibilities

• Develop, draft, review, and route validation protocols and test scripts for computerized systems
• Ensure compliance of validation activities with regulatory requirements and industry standards
• Collaborate with IT/OT teams and quality partners to align validation strategies with existing GMP systems

Required qualifications

• Bachelor's degree in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Computer Science, Biology, Technology, or a related life sciences discipline
• Minimum 5 years of experience as a Validation Professional
• Proven experience developing and executing validation protocols for computerized systems
• Strong knowledge of FDA, EMA, GxP, and industry standards related to system validation
• Solid understanding of Computerized System Validation (CSV)