CQV Engineer

Overview

The CQV Engineer is tasked with the qualification and calibration of laboratory equipment and instrumentation utilized within the operations laboratory. The scope of responsibilities encompasses the installation, qualification, and calibration of both simple (e.g., plate sealers) and complex (e.g., liquid handling robotics) instrumentation in the laboratory.

• Qualify all instruments, while creating and updating equipment protocols as necessary.
• Provide support for new instrumentation and project deliverables.
• Develop and revise instrument qualification protocols in accordance with design requirements, operational needs, and applicable standards.
• Coordinate the installation of new automation equipment by liaising with necessary groups to ensure that all required MEPs are in place.
• Collaborate with process engineering and QA teams to facilitate the introduction of new equipment types into the clinical laboratory.
• Engage with various departments to ascertain qualification (IQ/OQ/PQ) and calibration requirements for incoming instruments, as needed, to ensure compliance with regulations and meet process requirements.
• Maintain a program for the calibration of all laboratory equipment.
• Recommend and implement changes to ensure the ongoing high-quality performance of laboratory equipment.
• Execute all service activities in compliance with all relevant safety and regulatory bodies (e.g., OSHA, CAP, CLIA, etc.).
• Maintain and continuously enhance knowledge and expertise related to the service of clinical laboratory equipment.
• Exhibit excellent verbal and written communication skills in English.
• Demonstrate adaptability, openness to change, and the ability to operate in ambiguous situations while responding to new information and unexpected circumstances.
• Possess strong interpersonal and teamwork skills; able to effectively convey concepts and priorities, as well as solicit feedback and inputs.
• Support and adhere to the company’s Quality Management System policies and procedures.
• Undertake additional tasks as specified by the supervisor/manager.
• This role involves regular interaction with PHI in both paper and electronic forms and requires access to various technologies to manage PHI (paper and electronic) to perform job functions.
• Employees must complete training related to HIPAA/PHI privacy, General Policies and Procedure Compliance training, and security training at the earliest opportunity, but no later than within the first 30 days of hire.
• It is essential to maintain current status on Natera training requirements.

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

• Proficient in analyzing and problem-solving issues.
• Excellent attention to detail and accuracy.
• Ability to foster a positive team environment.
• The candidate must be a self-starter capable of independently driving projects and day-to-day tasks to completion according to schedule.
• Adaptability in a frequently changing environment.
• Maintain a high level of professionalism and responsibility.
• Strong technical writing and communication skills.
• Must possess strong interpersonal and organizational skills.
• Proficient in computer skills (MS Word, Excel, PowerPoint, etc.).
• Familiarity with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, etc.
• Experience with automation and sequencing instrumentation.

Natera9 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.…