All About Us
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.
lllumina has experienced phenomenal growth from $10 million in revenues in 2002 to approximately $2.2 billion in 2015. Forbes named Illumina #1 on the 2009 list of 25 Fastest-Growing Technology Companies in the United States, the second time over a three year period that Forbes ranked Illumina #1 on its list of rapidly growing technology companies. Illumina was also named #1 smartest company in the world as part of MIT’s 2014 Technology Review. As of February 2016, the company had a $21 billion market capitalization.
The Validation Engineer 2 has primary responsibility for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program.
All About You
- Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility.
- Contribute and help write procedures for the Calibration and Environmental Monitoring program sustaining activities.
- 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
- 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 and FDA regulated environment.
- Knowledge and working application of FDA, and cGMP requirements.
- Intermediate knowledge and working application of Validation Principles and guidelines and industry practice.
- Knowledge in Calibration and Environmental Monitoring Programs.
- 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.
- Computer competency in MS Office.
- BS Degree in Engineering or Science and/or a minimum of 3 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.