US_East | Manufacturing & Process Engineer_L

Qualification/Validation Engineer

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.

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.

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.