[Hiring] Computer System Validation Specialist @Natera

Role Description

The Computer System Validation Specialist will work with the Natera Software Engineering team to ensure appropriate software documentation is in place to support changes to Laboratory and Product software systems. Working with the QA Software Manager, this position will provide value-added guidance throughout the software development lifecycle process.

Primary Responsibilities

• Participate in software risk management activities
• Perform risk and/or impact assessments for Lab, Product, and Quality Management software systems
• Review software change requests and maintenance updates along with associated test plans, protocols, and reports
• Participate and/or lead computer system validation projects
• Draft IQ/OQ/PQ software plans, protocols, and reports
• Ensure validation state of software systems are maintained
• Act as subject matter expert for CSV compliance during internal and external audits
• Perform audit trail reviews
• Participate and/or lead cross-functional teams to investigate and resolve software nonconformities, deviations, CAPAs, and complaints
• May support quality system audits as subject matter expert in computer system validation
• Responsibilities are assigned based on demonstrated competency

Qualifications

• BS Degree or equivalent work experience
• 3-5 years’ experience within a dedicated CSV or product software validation role
• Experienced working in a CLIA Laboratory environment and/or FDA regulated environment

Requirements

• Preferred experience/knowledge with Microsoft Great Plains, Confluence, JIRA, SuccessFactors, LIMS, EDMS
• Extensive knowledge of QA methodologies, test planning, system dependencies, and product integration phases
• CSV III: Extensive knowledge of regulatory requirements for software design and change control (lifecycle management)
• Knowledge of regulatory requirements for non-product and product software (IEC 62304, 21 CFR Part 11, 21 CFR Part 820.30 and 820.70(i), CLIA, etc.)
• Strong knowledge of QA methodologies (such as root cause analysis), test planning, system dependencies, and product integration phases

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to talk or hear
• The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms
• Limited travel required

Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• 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
• Generous employee referral program

Company Description

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.