Description

You will perform computer system validations to ensure full compliance with regulatory requirements.

Responsibilities

• Execute computer system validations and document all processes to meet regulatory standards.
• Analyze and review validation deliverables including Validation Plans, Risk Assessments, and Validation Summary Reports.
• Review and approve technical documentation such as Test Plans, Requirement Specifications, and Functional Specifications.
• Write Test Plans and Validation Summary Reports for various IT tools.
• Conduct risk assessments, identify possible issues, and maintain Deviation Records.

Required Skills

• Experience with Validation Plan development.
• Proficiency in performing Risk Assessments.
• Ability to author and execute Test Plans.
• Experience documenting Requirement Specifications.
• Master’s degree in Mechanical Engineering or a related field.
• Minimum of 1 year of experience as a Validation Engineer or in a related role.

Key Skills

Education

Master’s degree in Mechanical Engineering