Senior Validation Engineer at Illumina, Inc. in San Diego, California

Job Description:

We are looking for a driven, talented Senior Validation Engineer 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 system validation deliverables/activities for manufacturing systems.

Responsibilities:

• Develop and execute IQ, OQ, and PQ protocols for manufacturing process systems and software.


• Write and execute manual tests for software and system validation. Carefully analyze and document test results.


• Write reports summarizing results and statistics for manufacturing process systems and software validation projects.


• Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.


• Operate various laboratory instrumentation and simulators to perform integration testing, system testing, and functionality testing with new software.


• Assist software developers and domain experts in designing, performing, and improving verification tests.


• Ensure validation program meets requirements of FDA (21 CFR 820 and 21 CFR 11) and ISO13485:2016.


• Work with scientists, technicians, engineers, and project management to develop new software or sustain validated software.


• Coordinate and participate in developing, testing, and implementing interim and long-term processes and technology solutions, including software testing and system-level testing with new software.


• Interact with cross-disciplinary project teams to meet project milestones and end goals.


• Learn and understand the applicable technology and engage in technical discussions.


• Provide consultation to other departments performing validation activities.


• Lead cross-functional teams to address software and system-level issues.

Requirements:

• Knowledge and working application of Validation Principles and guidelines and industry practice, FMEA, and Risk Analysis.


• This position requires previous software testing experience in a regulated industry.


• Demonstrate strong analytical problem solving (CAPA) and the ability to write and follow standard operating procedures.


• Computer competency in MS Office.


• The right candidate must have excellent interpersonal, written, and verbal communication skills.


• Adaptable to a fast-paced, dynamic work environment with the ability to manage projects methodically.


• Candidate must have a deep understanding of Good Automated Manufacturing Practices (GAMP 5), General Principles of Software Validation (GPSV), and part 11 compliance.


• Experience with statistics, Statistical Process Control, and DOE techniques is a plus.


• ASQ certifications (CSQE, CQE, CMQ/OE) are a plus.

Education & Experience:

• Bachelors' degree in engineering or science and a minimum of five years of related experience. 


• Experience in the medical device/IVD or regulated industry in the deployment of Quality Systems, process controls, and continuous improvement methods.


• Minimum of five years manufacturing/quality assurance engineering experience in an FDA-regulated environment is strongly preferred.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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 require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

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