Commission, Qualification and Validation (CQV) Engineer

San Carlos, CA, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Are you a detail-oriented and driven engineer looking for an exciting new opportunity? Look no further! Natera is seeking a Commission, Qualification and Validation (CQV) Engineer to join our dynamic team. As a CQV Engineer, you will play a crucial role in ensuring the quality and reliability of our cutting-edge medical products. Your expertise in commissioning, qualification, and validation processes will be essential in meeting regulatory requirements and maintaining the highest standards of excellence. If you are passionate about making a difference in the healthcare industry and have a strong background in engineering, we want to hear from you. Join us and be a part of our mission to revolutionize the field of genetic testing.

Develop and implement commissioning, qualification, and validation plans for new and existing medical products, in compliance with regulatory requirements and industry standards.
Conduct thorough and accurate testing and analysis of products and equipment to ensure quality and reliability.
Collaborate with cross-functional teams to establish and maintain standard operating procedures for commissioning, qualification, and validation processes.
Troubleshoot and resolve any issues related to commissioning, qualification, and validation, and provide recommendations for improvements.
Keep up-to-date with industry trends and best practices, and apply them to continuously improve the CQV process.
Maintain detailed documentation and records of all commissioning, qualification, and validation activities, ensuring compliance with regulatory guidelines.
Work closely with regulatory agencies during audits and inspections, providing necessary documentation and information.
Provide guidance and training to team members on commissioning, qualification, and validation processes.
Participate in the design and development of new products, providing input on quality and reliability considerations.
Identify areas for improvement in product design and manufacturing processes, and work with relevant teams to implement changes.
Communicate effectively with internal and external stakeholders, including engineers, scientists, and regulatory authorities.
Adhere to company policies and procedures, and promote a culture of quality and excellence.
Continuously monitor and evaluate the effectiveness of commissioning, qualification, and validation processes and make recommendations for improvement.
Participate in cross-functional projects and initiatives to support the overall goals and objectives of the company.
Foster a positive and collaborative work environment, promoting teamwork and professional development.

Where is this job?

This job is located at San Carlos, CA, USA

Job Qualifications

Bachelor's Degree In Engineering Or A Related Field: A Cqv Engineer At Natera Should Have A Strong Foundation In Engineering Principles And Concepts, Which Can Be Obtained Through A Bachelor's Degree In Engineering Or A Related Field Such As Bioengineering Or Chemical Engineering.
Experience In The Biotechnology Or Pharmaceutical Industry: Natera Is A Biotechnology Company, And A Cqv Engineer Should Have Prior Experience Working In A Similar Industry. This Ensures That The Candidate Has An Understanding Of The Regulatory Requirements And Quality Standards Specific To The Biotech Field.
Knowledge Of Commissioning, Qualification, And Validation Processes: As The Job Title Suggests, A Cqv Engineer At Natera Should Have A Thorough Understanding Of Commissioning, Qualification, And Validation Processes. This Includes Knowledge Of Industry Standards Such As Gmp, Gamp, And Fda Regulations.
Strong Analytical And Problem-Solving Skills: Cqv Engineers At Natera Are Responsible For Troubleshooting And Resolving Issues Related To Equipment, Processes, And Systems. Therefore, Strong Analytical And Problem-Solving Skills Are Essential For This Role.
Attention To Detail And Strong Documentation Skills: The Cqv Process Involves Extensive Documentation Of Procedures, Protocols, And Test Results. A Cqv Engineer At Natera Should Have Excellent Attention To Detail And Strong Documentation Skills To Ensure Accuracy And Compliance With Regulatory Requirements.

Required Skills

Quality Assurance
Project Management
Data Analysis
Root Cause Analysis
Validation protocols
Risk assessment
Process optimization
Documentation management
GMP compliance
Technical Expertise
Equipment Qualification

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Organization
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Commission, Qualification and Validation (CQV) Engineer in San Carlos, CA, USA is between $87,000 and $130,000 per year. This range can vary depending on factors such as years of experience, education level, and specific skills or certifications.

Additional Information

Natera is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedApril 7th, 2025

Apply BeforeMay 22nd, 2025

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