MES Validation Engineer

Job Summary

A company is looking for a MES Validation Engineer.

Key Responsibilities

• Develop, draft, and route test scripts and validation protocols for computer systems in compliance with regulatory standards
• Collaborate with ITOT, system owners, quality partners, and business process owners to align strategies with existing GMP systems
• Execute formal validation in a GMP environment and provide input on validation strategies

Required Qualifications

• 5 years of experience as a Validation Professional with proven experience in developing and executing validation protocols for computer systems
• Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation
• Ability to assess and mitigate risks associated with computer systems
• Solid understanding of Computerized System Validation (CSV)
• Bachelor's degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science, or a related life sciences discipline