MES Validation Engineer

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