Computer Systems Validation Engineer

Job Summary

Working remotely within the United States, the full-time Computer Systems Validation Engineer will ensure that computerized systems are validated, maintained, and compliant with regulatory requirements while collaborating with various stakeholders to uphold data integrity and security.

Key responsibilities

• Plan, execute, and maintain validation activities for computerized systems in accordance with GAMP 5 and applicable GxP regulations
• Develop and maintain validation documentation, including Validation Plans, User Requirements Specifications, and Validation Summary Reports
• Perform system risk assessments and ensure systems remain in a validated state through periodic reviews and change control

Required qualifications

• Strong knowledge of GAMP 5 guidelines, FDA 21 CFR Part 11, and data integrity rules
• Minimum of 4 years of direct CSV experience in a regulated life sciences or clinical research field
• Hands-on experience with the validation of life sciences/clinical applications such as QMS and CTMS
• Preferred degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience
• Highly organized with the ability to manage multiple priorities in a fast-paced environment