Position : Process / Equipment Validation Engineer
Location : Austin, TX
Contract : 6 months
Hours : 8–5 (flexible as needed)
Rate : $50–$55 / hr
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.
Key Responsibilities
- 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
Requirements
Bachelor’s degree in Engineering or related field with 5–6 years of experience in medical device, pharmaceutical, or biotech manufacturingStrong knowledge of applicable quality and regulatory standards (e.g., FDA, ISO, GAMP)Hands-on experience with manufacturing equipment validation and statistical analysisAbility to work independently, manage multiple priorities, and make sound technical decisionsStrong communication and problem-solving skillsFacilities validation experience in a 24 / 7 manufacturing environment preferred