Computer System Validation Engineer

Job Summary

A company is looking for a Computer System Validation Engineer to support validation activities for GMP facilities.

Key Responsibilities

• Act as lead SME for CSV projects and provide updates on project status and risk-based issues
• Review and approve software validation documentation to ensure compliance with regulations
• Organize or conduct training on software validation principles and maintain the validation state of systems

Required Qualifications

• BS/BA Degree in Computer Science, IT, Engineering, Science, or Business
• 3 - 5 years of experience in CSV or product software validation roles
• Proficient SAP validation experience and knowledge of regulatory compliance in FDA regulated environments
• Experience with large systems such as EtQ, LIMS, and electronic batch records
• Strong understanding of FDA Quality System Regulation and ISO/EU standards related to software validation