Commission, Qualification and Validation (CQV) Engineer II

Natera • Austin, TX

309d • $74,800 - $93,500

About The Position

We are seeking a Commission, Qualification and Validation (CQV) Engineer II to support the commissioning and validation of laboratory and robotic equipment. The ideal candidate will have hands-on experience in writing and executing IQ, OQ, and PQ protocols to ensure compliance with regulatory and quality standards.

Requirements

• BS/BA in a biological science/biomedical engineering, similar field of study, or comparable industry experience.
• 1 years of industry-related experience.
• Experience supporting lab equipment or similar required.

Nice To Haves

• Familiar with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, etc.
• Experience operating automation or sequencing instrumentation.

Responsibilities

• Edit and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for complex laboratory and robotic equipment.
• Perform equipment verification and validation to ensure functionality, reliability, and compliance.
• Collaborate with cross-functional teams (engineering, QA, and operations) during equipment commissioning and qualification activities.
• Prepare detailed validation reports and documentation for audits and inspections.
• Support troubleshooting and remediation activities for equipment performance issues.
• Maintain a program for preventative maintenance (PM), routine maintenance, and calibration of laboratory equipment.
• Recommend and implement changes to ensure ongoing high-quality performance of laboratory equipment.
• Perform all service activities in compliance with all relevant safety and regulatory bodies (e.g., OSHA, CAP, CLIA, etc.).
• Maintain and continuously develop knowledge and expertise related to the service of clinical laboratory equipment.
• Track all service activities utilizing system(s) developed in accordance with service procedures and laboratory policies.
• Ensure all service documentation is complete, timely, and accurate following Good Documentation Practices (GDP).
• Support and comply with the company's Quality Management System policies and procedures.
• Perform other tasks as specified by the supervisor/manager.

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits.
• Commuter benefits.
• Generous employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree