Process Equipment Validation Engineer

Job Summary

We are seeking a Process Validation Engineer to support medical device manufacturing in Austin, Texas. Reporting to the Validation Quality Manager, this role focuses on equipment and process validation to ensure compliance with internal and regulatory requirements.

• Lead equipment and process validation activities from planning through completion
• Oversee IQ, OQ, PQ, and TMV to ensure regulatory and quality compliance
• Develop, execute, and review validation documentation, including protocols, reports, risk assessments, and change controls
• Ensure validation activities follow approved procedures and documentation standards
• Partner with cross-functional teams on technical, quality, and continuous improvement efforts
• Assess validation approaches, resolve technical issues, and recommend compliant solutions
• Support facilities validation and related quality engineering initiatives as needed

• Bachelor’s degree in Engineering or related field with 5–6 years of experience in medical device, pharmaceutical, or biotech manufacturing
• Strong knowledge of applicable quality and regulatory standards (e.g., FDA, ISO, GAMP)
• Hands-on experience with manufacturing equipment validation and statistical analysis
• Ability to work independently, manage multiple priorities, and make sound technical decisions
• Strong communication and problem-solving skills
• Facilities validation experience in a 24/7 manufacturing environment preferred