Commission, Qualification and Validation (CQV) Engineer II

Natera • Austin, TX

8d

About The Position

The CQV Engineer is responsible for service and support of laboratory equipment and instrumentation used in the Operations laboratory, including installation, calibration, maintenance, and repair of simple and complex instruments. The engineer serves as the primary point of contact for production lab personnel when equipment is not operating or does not meet operational specifications, providing Level 2 support and coordinating escalated issues with Level 3 support, Automation, and vendors.

The role supports instrument qualification, new equipment installations, automation projects, preventive maintenance, routine maintenance, and calibration. It collaborates with laboratory, Automation, process engineering, QA, and other teams to introduce new equipment and meet regulatory and process requirements. The role also maintains service records and documentation in accordance with service procedures, laboratory policies, and Good Documentation Practices, and complies with relevant safety and regulatory requirements and the company’s Quality Management System.

The position regularly involves access to protected health information (PHI) in paper and electronic form. The employee must complete required HIPAA/PHI privacy, general policy and procedure compliance, and security training within the first 30 days of hire and maintain current status on Natera training requirements. Other duties may be assigned by the supervisor or manager.

Requirements

• BS/BA in biological science, biomedical engineering, a similar field of study, or comparable industry experience.
• 1–3 years of industry-related experience.
• Experience supporting laboratory equipment.
• Ability to analyze and solve problems.
• Excellent attention to detail and accuracy.
• Ability to promote a positive team environment.
• Self-starter able to independently drive projects and day-to-day work tasks to completion according to schedule.
• Adaptability in a frequently changing environment.
• High level of professionalism and responsibility.
• Good technical writing and communication skills.
• Strong interpersonal and organizational skills.
• Computer skills, including MS Word, Excel, and PowerPoint.
• Familiarity with DNA isolation and purification, PCR, cell culture, and sequencing.
• Excellent verbal and written English communication skills.
• Ability to work in ambiguous situations and respond to new information and unexpected circumstances.
• Ability to convey concepts and priorities and solicit feedback and input.
• Ability to access and handle PHI in paper and electronic form as part of the job.

Nice To Haves

• Experience with automation and sequencing instrumentation.

Responsibilities

• Provide Level 2 support for laboratory equipment, troubleshooting hardware and software with support from Level 3, Automation, and vendors as needed.
• Work with Instrument Service Engineers, Automation, and laboratory teams to respond to instrument failures and ensure instruments function properly.
• Diagnose and troubleshoot system concerns to minimize downtime.
• Install laboratory equipment, including liquid handlers, sequencers, and plate sealers, to support laboratory capacity or new projects.
• Ensure instruments are appropriately qualified and create or update equipment protocols as needed.
• Support new instrumentation and project deliverables.
• Develop and execute procedures for cleaning and maintaining laboratory instrumentation.
• Develop and revise instrument qualification protocols in accordance with design requirements, operational needs, and applicable standards.
• Coordinate new automation equipment installations and contact necessary groups to ensure required MEPs are in place.
• Work with process engineering and QA teams to facilitate introduction of new equipment types into the clinical laboratory.
• Coordinate with departments to determine IQ/OQ/PQ, calibration, and preventive maintenance requirements for incoming instruments, as needed, to comply with regulations and process requirements.
• Maintain preventive maintenance, routine maintenance, and calibration programs for laboratory equipment.
• Coordinate escalated service concerns with Level 3 support and vendors.
• Recommend and implement changes to support ongoing high-quality performance of laboratory equipment.
• Perform service activities in compliance with applicable safety and regulatory requirements, including OSHA, CAP, and CLIA.
• Maintain and develop knowledge and expertise related to servicing clinical laboratory equipment.
• Track service activities using systems established in accordance with service procedures and laboratory policies.
• Ensure service documentation is complete, timely, and accurate in accordance with Good Documentation Practices.
• Support and comply with the company’s Quality Management System policies and procedures.
• Coordinate duties with the Equipment Technician.
• Complete required HIPAA/PHI privacy, general policy and procedure compliance, and security training within the first 30 days of hire, and maintain current status on Natera training requirements.
• Perform other tasks specified by the supervisor or 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.
• 401(k) benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level