Sr Validation Engineer

Position: Senior Validation Engineer – Automated Medical Device Assembly

Location: Tempe, AZ 85288

Schedule: 100% onsite, 5 days per week

Duration: 18-24 months

I am looking for a Senior Validation Engineer to join my Sterling Engineering team. In this role you will qualify and validate new automated assembly lines used to manufacture a wearable medical device.

This is a hands-on role supporting enclosed, conveyor-based assembly equipment operating within a cleanroom environment. You will support two lines concurrently and must be able to independently develop protocols, execute testing, investigate issues, and complete validation documentation.

Responsibilities:

• Support Site Acceptance Testing (SAT) of automated assembly equipment.
• Develop and execute Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) protocols.
• Validate complete assembly lines, including individual equipment modules and interactions between assembly loops.
• Use User Requirements Specifications (URS) to develop test procedures, acceptance criteria, and requirements traceability.
• Verify equipment operation, alarms, fault responses, interlocks, and recovery sequences against approved requirements.
• Partner with Automation, Equipment Engineering, Manufacturing, and Quality to investigate line stoppages and document resolution and retesting.
• Support qualification of operating ranges and production performance against approved requirements.
• Prepare validation reports and maintain clear, accurate execution records.
• Coordinate validation activities across two assembly lines.
• Follow cleanroom gowning and PPE requirements.
• Potentially support additional cleanroom validation activities in 2027.

Qualifications:

• Must have 7–10 years of relevant equipment and process validation experience in the U.S.
• Must have experience in sterile medical device manufacturing or aseptic environments is preferred.
• Medical device manufacturing experience required.
• Direct experience qualifying automated assembly lines and manufacturing equipment.
• Hands-on SAT and IQ/OQ/PQ protocol development and execution.
• Experience translating URS requirements into documented testing.
• Strong technical writing, troubleshooting, and deviation documentation skills.
• Experience working in cleanroom manufacturing environments.
• Ability to independently manage validation activities with minimal training.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.