CQV Engineer

Natera • San Carlos, CA

1d

About The Position

The CQV Engineer is responsible for servicing and supporting laboratory equipment and instrumentation used in the Operations laboratory, including installation, calibration, maintenance, and repair of both simple and complex instruments. The engineer serves as the primary contact for production laboratory personnel when equipment is not operating or does not meet operational specifications. The role provides Level 2 support, troubleshoots hardware and software, coordinates escalations with Level 3 support, Automation, and vendors, and helps maintain reliable laboratory operations. It also supports new instrumentation and projects, develops and executes maintenance and qualification procedures, and collaborates with laboratory, Automation, process engineering, and QA teams to introduce and qualify equipment. Service activities must comply with applicable safety and regulatory requirements, company quality policies, and Good Documentation Practices. The position regularly involves access to protected health information (PHI), and requires completion and maintenance of applicable privacy, security, and company training.

Requirements

• Bachelor’s degree in biological science, biomedical engineering, or a similar field, 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.
• Ability to independently drive projects and day-to-day tasks to completion according to schedule.
• Adaptability in a frequently changing environment and ability to work amid ambiguity and unexpected circumstances.
• Professionalism and responsibility.
• Good technical writing and communication skills, including excellent verbal and written English communication skills.
• Strong interpersonal and organizational skills, with the ability to communicate concepts and priorities and solicit feedback and input.
• Computer skills, including MS Word, Excel, and PowerPoint.
• Familiarity with DNA isolation and purification, PCR, cell culture, sequencing, or related laboratory processes.

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 equipment functions properly.
• Diagnose and troubleshoot system concerns to minimize downtime.
• Install new 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 qualification (IQ/OQ/PQ), calibration, and preventive maintenance requirements for incoming instruments.
• Maintain preventive maintenance, routine maintenance, and calibration programs for laboratory equipment.
• Coordinate with Level 3 support and vendors to resolve escalated service concerns.
• Recommend and implement changes to support ongoing high-quality equipment performance.
• Perform service activities in compliance with relevant safety and regulatory requirements, including OSHA, CAP, and CLIA.
• Maintain and develop knowledge and expertise related to clinical laboratory equipment service.
• Track service activities using systems developed 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 company 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 as specified by the supervisor or manager.

Benefits

• Comprehensive medical, dental, and vision benefits.
• Life and disability plans for eligible employees and their dependents.
• 401(k) with company match.
• Generous paid time off and company holidays.
• Wellness and work-life benefits.
• Fertility care benefits and free testing for employees and their immediate families.
• Pregnancy and baby bonding leave.
• Commuter benefits.
• Employee referral program.

What This Job Offers

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