Validation/Quality Technician

Job Title: Validation/Quality Technician

Max Pay Rate: $31/hr

Duration: 12+ Months

Location: Onsite Newton, NC

 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.

 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.

 Qualifications: Education:

·         Associate or bachelor’s degree in engineering, science, or a related technical field. Relevant certifications may be considered.

·         Experience: 1–3 years of experience in equipment qualification or a related role.

 Technical Skills:

·         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.

·         Soft Skills:

·         Strong analytical and problem-solving skills.

·         Excellent written and verbal communication.

·         Attention to detail and ability to follow procedures precisely.

·         Other Requirements:

·         Ability to work independently and as part of a team.

·         Willingness to travel to different sites when necessary.

·         Physical ability to handle equipment and perform inspections.

 Work Environment:

·         May involve working in laboratories, manufacturing facilities, or cleanroom environments.

·         Requires adherence to safety protocols and use of personal protective equipment (PPE) as needed.

·         This role is critical for ensuring equipment reliability and regulatory compliance, supporting the success and integrity of operational processes.