Qualification/Validation Engineer

Global Business Ser. 4u; Phoenix (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Global Business Ser. 4u in Phoenix, AZ is seeking a Qualification/Validation Engineer to lead IQ/OQ/PQ activities for equipment and HVAC systems in a regulated manufacturing setting.

You will document the installation, testing, deviations, and corrective actions, ensuring compliance with FDA and cGMP standards, and collaborate with cross-functional teams to maintain audit-ready records.

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.
• 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.

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.

Skills

IQ/OQ/PQ processes

Regulatory compliance

Analytical skills

Communication skills

Experience in equipment qualification

Problem-solving skills

Education

Bachelor’s degree in engineering or Life Sciences

Job description

Work location: Phoenix , AZ
Background and Meet and Greet: MANDATORY

• 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.

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.