Equipment Quality Technician SINDC
Listed on 2026-02-16
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Engineering
Quality Engineering, Validation Engineer, Biomedical Engineer, Process Engineer
Job Title: Quality Technician / Equipment Qualification Technician
Location: 1500 Prodelin Drive, Newton, NC 28658
Position Summary
The Equipment Qualification Technician is responsible for ensuring that manufacturing and laboratory equipment meets established performance, reliability, and regulatory requirements. This role supports equipment validation and qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure compliance with internal quality standards and applicable regulatory guidelines. The position plays a critical role in maintaining equipment reliability, supporting operational excellence, and ensuring product quality.
Key Responsibilities
Equipment Qualification & Validation
- Perform IQ, OQ, and PQ protocols for new and existing equipment
- Verify equipment compliance with regulatory standards and internal quality requirements (e.g., GMP, ISO, FDA, OSHA)
- Document qualification activities, results, deviations, and corrective actions
- Perform hands-on troubleshooting and technical support for newly installed or modified equipment
- Collaborate with Subject Matter Experts (SMEs) to perform Root Cause Analysis (RCA)
Testing, Calibration & Troubleshooting
- Conduct routine equipment testing and calibration to ensure proper performance
- Identify, troubleshoot, and resolve equipment performance issues
- Utilize diagnostic tools and calibration instruments to support qualification activities
Documentation & Compliance
- Prepare detailed reports documenting qualification protocols, execution, and outcomes
- Maintain accurate, complete, and up-to-date qualification and calibration records
- Support audits and inspections by providing documentation and technical input
- Ensure adherence to GMP, GLP, ISO, and other applicable regulatory standards
Training & Cross-Functional Support
- Work with trained operators to learn equipment setup and operation
- Provide training and technical guidance to operators and support staff
- Collaborate with Engineering, Maintenance, and Quality teams to ensure proper equipment operation and care
- Identify opportunities to improve equipment qualification and validation processes
- Apply structured problem-solving and process improvement methodologies such as FMEA, Six Sigma, DOE, DMAIC, Fishbone Diagrams, Hypothesis Trees
- Stay current with evolving regulatory requirements and industry best practices
Qualifications
Education
- Associate’s or Bachelor’s degree in Engineering, Science, or a related technical field
- Relevant certifications may be considered in lieu of formal education
Experience
- 1–3 years of experience in equipment qualification, validation, or a related technical role
Technical Skills
- Working knowledge of equipment qualification protocols (IQ/OQ/PQ)
- Familiarity with regulatory and industry standards (ISO, OSHA, GMP, GLP)
- Experience with industrial equipment operation, calibration, and troubleshooting
- Proficiency with diagnostic tools and calibration equipment
Soft Skills
- Strong analytical and problem-solving abilities
- Excellent written and verbal communication skills
- High attention to detail with the ability to follow procedures precisely
- Ability to work independently and collaboratively in a team environment
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