Commission, Qualification and Validation (CQV) Engineer II

Natera; Austin (TX); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

401k

Commuter benefits

Employee referral program

Job summary

Natera is seeking a CQV Engineer to support and service laboratory equipment in our Operations lab. The role includes installation, calibration, maintenance, and repair of instruments from simple plate sealers to complex liquid handling robotics.

You will be the primary contact for lab personnel when equipment is not operating correctly. Responsibilities include troubleshooting, instrument qualification, PM programs, and collaboration with QA and automation teams to ensure regulatory compliance

Qualifications

• BS/BA in biological science/biomedical engineering or similar field.
• 3 years of related industry experience preferred.
• Experience supporting laboratory equipment is required.

Responsibilities

• Provides Level 2 support for all laboratory equipment and troubleshoots hardware/software.
• Install and qualify new laboratory equipment to support capacity and projects.
• Develop and maintain PM, IQ/OQ/PQ protocols, and calibration procedures.
• Coordinate with QA, process engineering, and automation teams for instrument introductions.
• Ensure compliance with OSHA, CAP, CLIA, GDP, and other regulations.

Skills

Analytical skills

Attention to detail

Team collaboration

Self-starter

Adaptability

Professional writing

Interpersonal skills

MS Office

DNA isolation

Automation experience

Education

BS/BA in biological sciences or biomedical engineering

Job description

Position Summary

The CQV Engineer is 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
• Computer skills (MS Word, Excel, PowerPoint, etc.)
• 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

• 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!

For more information, visit www.natera.com.

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. Link: https://www.natera.com/notice-of-data-collection-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 seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For More Information

• BBB announcement on job scams
• FBI Cyber Crime resource page