Our client, a Business Manufacturing And Supply company, is looking for a Equipment Qualification Technician III for their Newton, NC location.
Responsibilities:
- 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.
Equipment Qualification:
- 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.
Testing and Calibration:
- Conduct regular equipment testing and calibration to ensure proper functioning.
- Troubleshoot and resolve issues with equipment performance.
Documentation and Reporting:
- Prepare detailed reports documenting qualification processes, outcomes, and compliance.
- Maintain accurate and up-to-date records of all equipment qualifications and calibrations.
Compliance and Regulatory Standards:
- 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.
Equipment Maintenance and Support:
- Collaborate with engineering, maintenance, and quality teams to ensure proper equipment care and operation.
- Provide training and technical support to staff using qualified equipment.
Continuous Improvement:
- Identify opportunities to improve equipment qualification processes and implement best practices.
- Stay updated on changes to regulatory standards and industry advancements.
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Requirements:
- Associate or bachelor's degree in engineering, science, or a related technical field. Relevant certifications may be considered.
- 1-3 years of experience in equipment qualification or a related role.
- Knowledge of equipment qualification protocols (IQ, OQ, PQ).
- Familiarity with regulatory requirements (e.g., ISO, OSHA).
- Proficiency with diagnostic tools and calibration equipment.
- Industrial equipment operation and troubleshooting.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication.
- Attention to detail and ability to follow procedures precisely.
- Ability to work independently and as part of a team.
- Physical ability to handle equipment and perform inspections.
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Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities