US_East | Manufacturing & Process Engineer_L

Manufacturing Equipment Qualification (IQ/OQ/PQ) Engineer

Position Summary:

The Qualification Program (IQ/OQ/PQ) Administrator is responsible for overseeing the installation, operational, and performance qualification of equipment and systems in compliance with regulatory standards. This role ensures that all equipment operates within specified parameters and meets quality and safety requirements.

Key Responsibilities:

• Verify that equipment is installed according to manufacturer specifications 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 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.
• Conduct tests to ensure the equipment consistently performs according to specifications.
• 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.
• Stay updated on changes in regulations and adjust qualification protocols accordingly.
• Develop and conduct training programs for staff on IQ/OQ/PQ procedures and protocols.
• Promote awareness of qualification processes within the company.
• Implement monitoring systems to ensure adherence to qualification protocols.
• Conduct regular internal audits to identify areas for improvement and ensure compliance.
• Maintain detailed records of all qualification activities, including protocols, test results, and corrective actions.
• Ensure documentation is accurate and easily accessible for regulatory inspections.

Qualifications:

• Bachelor's degree in engineering, Life Sciences, or a related field.
• 3-5 years of experience in equipment qualification or 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.