Perform computer system validations to ensure compliance with requirements. Analyze and review validation deliverable like Validation Plan, Risk Assessment, Validation Summary Report in compliance with regulations. Review and approve related documents such as Validation Plan, Test Plan, Requirement Specification, Functional Specification, and Qualification Protocol. Write Test Plan, Validation Summary Report for the validation of IT tools. Prepare and document all aspects of the computer system validation to ensure compliance in accordance with rules and regulations. Analyze possible issues, risk assessment and mitigation and maintain Deviation Records.
Master’s degree in Mechanical Engineering or related plus 1 year of experience as a Validation Engineer or related.
Master’s degree in Mechanical Engineering