Qualification/Validation Engineer

Role: Qualification/Validation Engineer **Work location: Phoenix , AZ

Background and Meet and Greet: MANDATORY** Job Description

• Perform equipment and HVAC Qualification activities as per company standard operating procedures and site requirements.
• Document the installation process, including utility connections, environmental conditions, and component verification.
• Ensure all necessary documentation, such as manuals and certificates, are available and complete.
• Develop and approve IQ & OQ protocols that outline the tests to be performed to verify equipment operation.
• Conduct tests to ensure the equipment operates according to predefined specifications under normal operating conditions.
• Document test results, any deviations, and corrective actions taken.
• Develop and approve PQ protocols that outline the tests to be performed to verify equipment performance under actual production conditions.
• Document test results, any deviations, and corrective actions taken.
• Ensure all qualification activities comply with local and international regulatory standards, such as FDA and cGMP guidelines.

Key Responsibilities

• Develop and conduct execution of IQ/OQ/PQ protocols.
• Assist external contractor for external testing and documentation
• Implement monitoring systems to ensure adherence to qualification protocols.
• Maintain detailed records of all qualification activities, including protocols, test results, and corrective actions.
• Ensure documentation is accurate and easily accessible for regulatory inspections.

Mandatory Skills

• Bachelor’s degree in engineering, Life Sciences, or a related field.
• 3-5 years of experience in equipment qualification including HVAC validation in a regulated industry.
• Strong knowledge of IQ/OQ/PQ processes and regulatory standards.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Experience with cGMP and FDA regulations.
• Proficiency in data analysis and reporting tools.
• Ability to work collaboratively with cross-functional teams.