Commission, Qualification and Validation (CQV) Engineer II New Austin, TX

Natera, Inc.; Austin (TX); On-site; USD 85,000 - 115,000; Full time

Job summary

Natera, Inc. is seeking a CQV Engineer II in Austin, TX to provide Level 2 support for complex laboratory instrumentation, including installation, calibration, maintenance, and qualification.

You will collaborate with Automation and QA teams to minimize downtime and ensure instruments operate within specifications. Responsibilities include troubleshooting hardware/software, installing new equipment, developing qualification protocols, and maintaining maintenance programs while adhering to GDP

Qualifications

• BS/BA in a biological science, biomedical engineering, or related field.
• 1–3 years industry-related experience.
• Experience supporting laboratory equipment required.

Responsibilities

• Provide Level 2 support for laboratory equipment, troubleshooting hardware and software with some Level 3 assistance.
• Collaborate with Instrument Service Engineers, Automation and lab teams to address instrument failures.
• Install new laboratory equipment to support capacity or new projects.
• Qualify instruments and update equipment protocols as needed.
• Maintain PM programs and calibrations for all instruments.
• Ensure compliance with safety and regulatory requirements (e.g., OSHA, CAP, CLIA).

Skills

Problem solving

Attention to detail

Teamwork

Technical writing

Communication skills

Education

BS/BA in biological science or biomedical engineering

Tools

Automation instrumentation

Lab equipment experience

Job description

Commission, Qualification and Validation (CQV) Engineer II

Austin, TX

POSITION SUMMARY:

The CQV Engineeris responsible for the service and support of laboratory equipment and instrumentation utilized in the Operations laboratory. The scope of support includes installation, calibration, maintenance, and repair of both simple (e.g., plate sealers) and complex (e.g., liquid handling robotics) instrumentation in the laboratory. The Instrument Service Engineer will be the primary point of contact for production lab personnel when equipment and instruments are not operating or not meeting operational specifications.

PRIMARY RESPONSIBILITIES:

• Provides Level 2 support for all laboratory equipment, troubleshooting hardware and software with some support from Level 3, Automation, and vendor.
• Work with other Instrument Service Engineers, and the Automation and laboratory teams to respond to instrument failures and ensure proper instrument function, providing Level 2 support for all laboratory equipment.
• Diagnose and troubleshoot any system concerns to minimize downtime, with the technical skills of a Level II, troubleshooting hardware and software with some support from Level 3, Automation, and vendor.
• Install new laboratory equipment (e.g., liquid handlers, sequencers, plate sealers, etc.) to support lab capacity or new projects
• Qualify all instruments are appropriately qualified, creating and updating equipment protocols as needed.
• Support of new instrumentation and project deliverables.
• Develop and execute procedures for the cleaning and maintenance of laboratory instrumentation
• Develop and revise instrument qualification protocols in accordance with design requirements, operational needs, and applicable standards
• Coordinate new automation equipment installations by reaching out to necessary groups to ensure necessary MEPs are in place
• Work with process engineering and QA teams to facilitate introduction of new equipment types into clinical laboratory
• Work with different departments to determine qualification (IQ/OQ/PQ), calibration and preventive maintenance requirements for new incoming instruments, as needed, to comply with regulations and meet process requirements.
• Maintain program for preventative maintenance (PM), routine maintenance, and calibration of all laboratory equipment.
• Perform troubleshooting activities and provide Level 2 service; coordinate with Level 3’s and vendors to address escalated service concerns.
• 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).
• Excellent verbal and written English communication skills.
• Adaptable, open to change, and the ability to work in ambiguous situations while responding to new information and unexpected circumstances.
• Strong interpersonal and teamwork skills; ability to easily convey concepts and priorities, as well as an ability to solicit feedback and inputs.
• Support and comply with the company’s Quality Management System policies and procedures.
• Coordinate duties with Equipment Technician
• Perform other tasks as specified by the supervisor/manager
• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.

QUALIFICATIONS:

• BS/BA in a biological science/biomedical engineering, similar field of study, or comparable industry experience
• 1-3 years industry related experience
• Experience supporting laboratory equipment required

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to analyze and problem solve issues
• Excellent attention to detail and accuracy
• Ability to promote a positive team environment
• Candidate must be a self-starter who can independently drive projects and day-to-day work tasks to completion according to schedule
• Adaptability in a frequently-changing environment
• Maintain a high level of professionalism and responsibility
• Good technical writing and communication skills
• Must have strong interpersonal and organizational skills
• Familiar with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, etc.
• Experience with automation and sequencing instrumentation

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes serious, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Natera’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.