Senior Validation Specialist

Job Summary

A company is looking for a Principal Validation Specialist.

Key Responsibilities

• Provide technical leadership and accountability for validation packages and test method setups
• Develop validation strategies ensuring compliance with regulatory requirements
• Generate and execute computer validation documentation for commercial software releases

Key Requirements

• Minimum of 7 years of experience in life sciences in an academic or industry setting
• Experience managing multiple validation projects and directing vendor resources
• Thorough understanding of Life Cycle Validation and computer system validation requirements
• Extensive knowledge of validation within regulated GXP environments
• Understanding of industry standards for computer systems validation, including GAMP 5 and 21 CFR Part 11