Qualification & Validation Engineer - GMP/QA Focus

Global Business Ser. 4u; Phoenix (AZ); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

IQ/OQ/PQ processes

Regulatory compliance

Analytical skills

Communication skills

Experience in equipment qualification

Problem-solving skills

Ausbildung

Bachelor’s degree in engineering or Life Sciences

Jobbeschreibung

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.