Commission, Qualification and Validation (CQV) Engineer II

Natera • Austin, TX

9d

About The Position

The CQV Engineer is responsible for service and support of laboratory equipment and instrumentation used in the Operations laboratory. Support includes installation, calibration, maintenance, and repair of both simple and complex instrumentation. The engineer serves as the primary point of contact for production lab personnel when equipment is not operating or does not meet operational specifications.

The role provides Level 2 troubleshooting and service for laboratory equipment, working with Instrument Service Engineers, Automation, laboratory teams, Level 3 support, and vendors. It also supports new instrumentation and project deliverables, develops and executes cleaning and maintenance procedures, and creates or revises qualification protocols in accordance with design requirements, operational needs, and applicable standards. The position coordinates installations and works with process engineering and QA to introduce new equipment into the clinical laboratory.

The engineer maintains preventive and routine maintenance, calibration, and qualification programs; ensures service work complies with relevant safety and regulatory requirements; and keeps complete, timely, and accurate service documentation in accordance with Good Documentation Practices. The role supports the company’s Quality Management System, coordinates duties with the Equipment Technician, and handles protected health information (PHI). Required HIPAA/PHI, policy compliance, and security training must be completed as soon as possible and no later than 30 days after hire, and Natera training requirements must remain current.

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 tasks to completion according to schedule.
• Adaptability in a frequently changing environment and ability to work in ambiguous situations.
• High level of professionalism and responsibility.
• Good technical writing and communication skills, including excellent verbal and written English communication skills.
• Strong interpersonal and organizational skills; ability to convey concepts and priorities, solicit feedback, and work effectively with others.
• Computer skills, including MS Word, Excel, and PowerPoint.
• Familiarity with DNA isolation and purification, PCR, cell culture, sequencing, and related processes.
• 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 proper instrument function.
• Diagnose and troubleshoot system concerns to minimize downtime.
• Install new laboratory equipment, including liquid handlers, sequencers, and plate sealers, to support 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.
• Work with departments to determine IQ/OQ/PQ, calibration, and preventive maintenance requirements for new instruments as needed to meet regulations and process requirements.
• Maintain preventive maintenance, routine maintenance, and calibration programs for laboratory equipment.
• Coordinate with Level 3 support and vendors to address escalated service concerns.
• Recommend and implement changes to maintain high-quality laboratory equipment performance.
• Perform service activities in compliance with relevant safety and regulatory bodies, including OSHA, CAP, and CLIA.
• Maintain and develop knowledge and expertise related to servicing clinical laboratory equipment.
• Track service activities using systems established under service procedures and laboratory policies.
• Ensure service documentation is complete, timely, and accurate in accordance with Good Documentation Practices.
• Support and comply with company Quality Management System policies and procedures.
• Coordinate duties with the Equipment Technician.
• Complete required HIPAA/PHI privacy, General Policies and Procedure Compliance, and security training within the specified timeframe, and maintain current Natera training status.
• Perform other tasks as 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.
• 401k benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

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