Sr Software Validation Engineer

Illumina, Inc.
Job Location
San Diego, CA 92122
Job Description

All About Us

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.

We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.
Position Summary:

As a senior software and system validation Engineer at Illumina, you will work in a dynamic team-oriented environment; you will play a significant role in creating and validating manufacturing SW.


  • Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility.
  • Experienced in GAMP 5 and 21 CFR Part 11.
  • Write reports summarizing results and statistics for SW used in different equipment, or process.
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
  • Write and execute manual tests for SW and system validation. Carefully analyze and document test results.
  • Operate a variety of laboratory instrumentation and simulators to perform integration testing, system testing, and functionality testing with new SW
  • Assist software developers and domain experts in designing, performing, and improving verification tests
  • Ensure validation program meets requirements of FDA (21 CFR Part 11) and ISO.
  • Work with scientists, technicians, engineers, and project management to develop new SW or sustain validated SW
  • Formalize, standardize and document processes
  • Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including SW testing, and system level testing with new SW
  • Interact with cross-disciplinary project teams in order to meet project milestones and end goals
  • May lead cross-functional teams to address SW and system level issues


  • Experience in the medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
  • Experience in the biotech consumables, medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
  • 5-7 years in manufacturing/quality assurance engineering experience in and FDA regulated environment is strongly preferred.
  • Working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
  • Knowledge and working application of Validation Principles and guidelines and industry practice, FMEA and Risk Analysis.
  • Practical experience in product design and development.
  • Knowledge and working application of standard operating procedures.
  • Demonstrated ability to accomplish goals while working across departments is required, Ability to multi-task and methodically manage projects.
  • Demonstrated strong analytical problem solving (CAPA), team and communications/interpersonal skills.
  • Experience with statistics, Statistical Process Control and DOE techniques is a plus. PMP certified is a plus. ASQ Accreditations are a plus.

Requires a Bachelor, Masters or PhD. degree in engineering or computer science and a minimum of 5 years of related experience.

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

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