Validation Engineer 2 at Illumina, Inc.
Posted in Architecture 12 days ago.
This job brought to you by eQuest
Location: San Diego, California
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. Life at Illumina is about working with teammates who 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. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.
We are looking for a driven, talented Validation Engineer 2 to join our growing Validation Engineering Team. The Validation Engineering Team works as an integral part of our Consumables Manufacturing process supporting new product introduction, sustaining manufacturing, and supporting projects that increase quality and yield within our high volume production environments.
This individual will work in a dynamic team-oriented environment and has primary responsibility for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining validation deliverables/activities for manufacturing processes and equipment.
- Develop and execute IQ, OQ and PQ protocols for manufacturing processes, systems, and equipment.
- Write reports summarizing results and statistics for all equipment, product, or process validation projects.
- Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.
- Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities.
- Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports.
- Coordinate with end users and process owners to lead development of validation protocols.
- Learn and understand the applicable technology and engage in technical discussions.
- Identify areas and opportunities to improve manufacturing facilities, processes and equipment.
- Provide consultation to other departments performing validation activities
- Ensure validation program meets requirements of FDA and ISO
Requirements & Education:
- Requires a Bachelors, Masters or PhD degree in engineering or science and a minimum of 2 years of related experience.
- Experience in the biotech consumables, medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
- 1-3 years in manufacturing/quality assurance engineering experience in an FDA regulated environment is strongly preferred.
- Knowledge and working application of FDA and cGMP requirements.
- Intermediate knowledge and working application of Validation Principles and guidelines and industry practice, FMEA, and Risk Analysis.
- Knowledge and working application of standard operating procedures.
- Demonstrated ability to accomplish goals while working across departments is required.
- Demonstrated strong analytical problem solving (CAPA), team and communications/interpersonal skills.
- Computer competency in MS Office.
- Excellent interpersonal, written, and verbal communication skills.
- Adaptable to fast-paced, dynamic work environment with ability methodically manage projects.
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. If you have a disability or special need that requires accommodation, please contact us at 858-255-5081. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf