CQV Engineer

Natera•San Carlos, CA

2d•$88,300 - $110,350

About The Position

The CQV Engineer provides service and support for laboratory equipment and instrumentation used in the Operations laboratory. This includes installation, calibration, maintenance, qualification, and repair of simple and complex instruments. The role is the primary point of contact for production laboratory personnel when equipment is inoperable or fails to meet operational specifications, and provides Level 2 troubleshooting with escalation support from Level 3 personnel, Automation, and vendors. The position supports new instruments and project deliverables, develops and maintains qualification and maintenance procedures, coordinates equipment installations, and works with process engineering, QA, Automation, laboratory teams, and other departments to ensure instruments meet operational, regulatory, and process requirements. The engineer maintains service records and documentation in accordance with laboratory policies, service procedures, and Good Documentation Practices, and performs service activities in compliance with applicable safety and regulatory requirements. The role also involves regular access to protected health information (PHI) in paper and electronic form. The employee must complete required HIPAA/PHI privacy, policy compliance, and security training within the first 30 days of hire and maintain current status on Natera training requirements.

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 issues 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 work tasks to completion according to schedule.
Adaptability in a frequently changing environment.
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, sequencing, or related processes.
Excellent verbal and written English communication skills.
Ability to work through ambiguity and respond to new information and unexpected circumstances.
Ability to convey concepts and priorities, solicit feedback, and work collaboratively.

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 personnel, 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, such as 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 introduce new equipment types into the clinical laboratory.
Work with other departments to determine IQ/OQ/PQ qualification, calibration, and preventive maintenance requirements for incoming instruments.
Maintain the preventive maintenance, routine maintenance, and calibration program for laboratory equipment.
Coordinate escalated service concerns with Level 3 personnel and vendors.
Recommend and implement changes to maintain high-quality laboratory equipment performance.
Perform service activities in compliance with applicable 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 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 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 as specified by the supervisor or manager.