Qualification/Validation Engineer

Role: Qualification/Validation EngineerLocation: Phoenix, AZJob Description:Perform equipment and HVAC qualification activities in accordance with company standard operating procedures and site requirements.Document installation processes, including utility connections, environmental conditions, and component verification.Ensure all required documentation, including manuals and certificates, is complete and available.Develop and approve IQ and OQ protocols outlining tests required to verify equipment operation.Conduct testing to ensure equipment operates according to predefined specifications under normal operating conditions.Document test results, deviations, and corrective actions.Develop and approve PQ protocols outlining tests required to verify equipment performance under actual production conditions.Ensure all qualification activities comply with local and international regulatory standards, including FDA and cGMP guidelines.Key Responsibilities:Develop and execute IQ/OQ/PQ protocols.Support external contractors with testing and documentation activities.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, complete, and inspection-ready for regulatory audits.Mandatory Skills and Qualifications: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.Experience with cGMP and FDA regulations.Strong analytical and problem-solving skills.Excellent communication and interpersonal skills.Proficiency in data analysis and reporting tools.Ability to work effectively in cross-functional teams."All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran."