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Job Description

Position Summary: An Equipment Qualification Technician is responsible for ensuring that equipment used in manufacturing, laboratory, or other operational environments meets required standards of functionality, reliability, and compliance. They play a key role in validating and qualifying equipment to ensure it operates according to established specifications and regulatory requirements.

 

Key Responsibilities:

1. 
   
2. Equipment Qualification:
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   • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing equipment.
   • Ensure equipment meets regulatory standards (e.g., FDA, ISO, GMP, etc.) and internal quality requirements.
   • Document and report qualification results, including deviations and corrective actions.
   • Hands-on activities to troubleshoot and resolve technical issues with newly installed equipment.
   • Brainstorming with subject matter experts (SME) to do Root Cause Analysis (RCA).
   • Utilize standard process improvement methodologies such as FMEA, Six Sigma, DOE, Hypothesis Tree, DMAIC, Fishbone Diagram.
   • Work with trained operators to learn how to setup equipment and be trainer to train others.
3. Testing and Calibration:
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   • Conduct regular equipment testing and calibration to ensure proper functioning.
   • Troubleshoot and resolve issues with equipment performance.
4. Documentation and Reporting:
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   • Prepare detailed reports documenting qualification processes, outcomes, and compliance.
   • Maintain accurate and up-to-date records of all equipment qualifications and calibrations.
5. Compliance and Regulatory Standards:
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   • Ensure adherence to regulatory and industry standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ISO standards, or other applicable guidelines.
   • Assist in audits and inspections as needed.
6. Equipment Maintenance and Support:
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   • Collaborate with engineering, maintenance, and quality teams to ensure proper equipment care and operation.
   • Provide training and technical support to staff using qualified equipment.

 

 

6. 
   
7. Continuous Improvement:
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   • Identify opportunities to improve equipment qualification processes and implement best practices.
   • Stay updated on changes to regulatory standards and industry advancements.