Commission, Qualification and Validation CQV Engineer II

Natera
US - Texas - Austin
December 16, 2024

Position Summary
We are seeking a Commission, Qualification and Validation (CQV) Engineer II to support the commissioning and validation of laboratory and robotic equipment. The ideal candidate will have hands-on experience in writing and executing IQ, OQ, and PQ protocols to ensure compliance with regulatory and quality standards.
Primary Responsibilities:

Edit and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for complex laboratory and robotic equipment.
Perform equipment verification and validation to ensure functionality, reliability, and compliance.
Collaborate with cross-functional teams (engineering, QA, and operations) during equipment commissioning and qualification activities.
Prepare detailed validation reports and documentation for audits and inspections.
Support troubleshooting and remediation activities for equipment performance issues.
Maintain a program for preventative maintenance (PM), routine maintenance, and calibration of laboratory equipment.
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.
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
Employees 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 years of industry-related experience.
Experience supporting lab equipment or similar 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
Adaptability in a frequently-changing environment
Normally receives general instructions on routine work, detailed instructions on new projects or assignments
Maintain a high level of professionalism and responsibility
Must have strong communication, interpersonal and organizational skills
Word processing and data management (MS Word, Excel, PowerPoint, etc.)

Preferred skills:

Familiar with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, etc.
Experience operating automation or sequencing instrumentation.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Austin, TX

$61,000-$76,300 USD

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!

For more information, visit ***.

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: ***/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

Read the full job description and apply online on the recuiter's web-site

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