Job Description

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Responsibilities:

Coordinate with end users and process owners to lead development of validation protocols and execute IQ, OQ, PQ and/or PPQ for manufacturing systems, process and/or software

Review of completed validation results for manufacturing systems, process and/or software

Analyze validation results statistically and write reports summarizing results for manufacturing systems, process and/or software

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

Ensure validation program meets requirements of FDA (21 CFR Part 11) and ISO 13485

Work as a team player to interact with cross-disciplinary project teams in order to meet project milestones and end goals in a timely manner

Collaborate with different stakeholders to resolve any identified issues pertaining to validation

Participate in project management meetings as Validation representative to provide advice to other departments on validation strategy and requirement as necessary

Learn and understand the applicable technology and engage in technical discussions

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

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Requirements:

Knowledge and working application of FDA and cGMP requirements

Knowledge and working application of validation principles and guidelines and industry practice, FMEA, and Risk Management

Proficient knowledge and working application of standard operating procedures, as well as process and system validation principles for regulated industries including: FDA cGMP; ISO 13485, ISO 14971, IVDD, FMEA, Risk Analysis and Design Controls and relevant regulations and requirements

Demonstrated ability to accomplish goals in collaboration with cross-functional teams

Excellent interpersonal and written skills; highly effective communication, facilitation, negotiation and teamwork skills are required

Computer competency in MS Office

Adaptable to fast-paced, dynamic work environment with ability to manage projects methodically

Familiar with the ALCOA concept

Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring

Demonstrated analytical problem-solving skills in self-directed manner and must be able to work on problems of a complex scope

Experience in the biotech consumables, medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods

Minimum 3 years in manufacturing/quality assurance engineering experience in an FDA regulated environment

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.

Illumina