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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.
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The Senior Validation Engineer has primary responsibility for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program. , this person will partner cross-functionally and cross-site with R&D, Quality, Facilities, Production, and other engineering groups to lead validation efforts, collaborate in developing validation strategies, and execute validation deliverables
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 resolve any identified issues to bring validation to acceptable levels.
- 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.
- 5 years minimum in validation or 10 years in process development and/or validation/quality 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 7 years of related experience
PMP certified or MBA preferred
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.