GA
Equipment Validation Engineer
Accepting applicationsGxP Associates · Washington, United States
Full-Time Entry aiasicaterf
Posted
2d ago
Category
Test
Experience
Entry
Country
United States
Job Summary
We are seeking a motivated and detail-oriented Equipment Validation Engineer with 0–3 years of experience to join our full-time team in Washington State. This role will support equipment qualification and validation activities within a regulated medical device manufacturing facility, ensuring compliance with FDA Quality System Regulations, ISO 13485 requirements, and company quality standards. The Equipment Validation Engineer will collaborate with cross-functional teams to execute IQ, OQ, and PQ protocols, maintain validation documentation, support equipment lifecycle management, and help ensure manufacturing systems remain in a validated state.
Key Responsibilities
Support the execution of equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
Prepare, review, and execute validation protocols, test scripts, reports, and supporting documentation.
Assist with commissioning and startup activities for new manufacturing equipment and production lines.
Collaborate with cross-functional teams to ensure compliance with quality and regulatory requirements.
Participate in risk assessments and validation planning activities for new and existing equipment.
Support investigations related to equipment deviations, nonconformances, and CAPA activities.
Review engineering drawings, specifications, and vendor documentation to support validation efforts.
Maintain validation records and documentation in accordance with Good Documentation Practices (GDP).
Assist with equipment requalification, preventive maintenance reviews, and change control assessments.
Support internal audits, external audits, and regulatory inspections.
Contribute to continuous improvement initiatives focused on equipment reliability and process efficiency.
Required Qualifications
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, or a related technical field.
0–3 years of experience in validation, quality, manufacturing, engineering, or medical device environments.
Basic understanding of equipment qualification and validation principles.
Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Documentation Practices.
Strong technical writing, analytical, and problem-solving skills.
Ability to work effectively in a cross-functional team environment.
Proficiency with Microsoft Office applications.
Preferred Qualifications
Internship, co-op, or hands-on experience in a medical device manufacturing facility.
Exposure to validation lifecycle activities and quality systems.
Experience supporting automated manufacturing equipment, packaging equipment, or laboratory instruments.
Knowledge of risk management methodologies and statistical analysis tools.
Familiarity with CAPA, change control, nonconformance management, and root cause investigations.
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We are seeking a motivated and detail-oriented Equipment Validation Engineer with 0–3 years of experience to join our full-time team in Washington State. This role will support equipment qualification and validation activities within a regulated medical device manufacturing facility, ensuring compliance with FDA Quality System Regulations, ISO 13485 requirements, and company quality standards. The Equipment Validation Engineer will collaborate with cross-functional teams to execute IQ, OQ, and PQ protocols, maintain validation documentation, support equipment lifecycle management, and help ensure manufacturing systems remain in a validated state.
Key Responsibilities
Support the execution of equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
Prepare, review, and execute validation protocols, test scripts, reports, and supporting documentation.
Assist with commissioning and startup activities for new manufacturing equipment and production lines.
Collaborate with cross-functional teams to ensure compliance with quality and regulatory requirements.
Participate in risk assessments and validation planning activities for new and existing equipment.
Support investigations related to equipment deviations, nonconformances, and CAPA activities.
Review engineering drawings, specifications, and vendor documentation to support validation efforts.
Maintain validation records and documentation in accordance with Good Documentation Practices (GDP).
Assist with equipment requalification, preventive maintenance reviews, and change control assessments.
Support internal audits, external audits, and regulatory inspections.
Contribute to continuous improvement initiatives focused on equipment reliability and process efficiency.
Required Qualifications
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, or a related technical field.
0–3 years of experience in validation, quality, manufacturing, engineering, or medical device environments.
Basic understanding of equipment qualification and validation principles.
Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Documentation Practices.
Strong technical writing, analytical, and problem-solving skills.
Ability to work effectively in a cross-functional team environment.
Proficiency with Microsoft Office applications.
Preferred Qualifications
Internship, co-op, or hands-on experience in a medical device manufacturing facility.
Exposure to validation lifecycle activities and quality systems.
Experience supporting automated manufacturing equipment, packaging equipment, or laboratory instruments.
Knowledge of risk management methodologies and statistical analysis tools.
Familiarity with CAPA, change control, nonconformance management, and root cause investigations.
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