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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.

Summary

The validation engineer 2 works as an integral part of the validation team supporting new product introduction, sustaining manufacturing, computerized system introduction / sustaining. Collaborate in a dynamic team-oriented environment and lead the effort for defining, implementing and maintaining validation for manufacturing processes and systems. Become highly proficient in use of Validation Life Cycle Management System.

Key Responsibilities

• Develops and articulates robust strategies for validation of processes/systems and generate validation plans
• Develops validation protocols for and oversee execution of IQ, OQ, PQ and manufacturing processes, systems and equipment in collaboration with end users and process owners
• Writes reports summarizing validation study results and statistics for manufacturing process, systems and software validation projects
• Writes and executes manual tests for software and system validation
• Analyzes and documents test results and generate validation reports
• May operate a variety of laboratory instrumentation and simulators to perform integration testing, system testing, and functionality testing with new software
• May assist software developers and domain experts in designing, performing, and improving verification tests
• Provides input for creation of requirements documents
• Learns, understands, and applies technologies pertinent to systems, processes and products; engage in technical discussions as required
• Participates in creation of risk management documents such as FMEA for systems and processes
• Ensures validation program meets requirements of FDA (21 CFR Part 11) and applicable international standards (e.g. ISO-13485)
• Collaborates with cross-disciplinary project teams to meet project milestones and end goals
• Provides consultation to other departments performing validation activities
• May lead cross-functional teams to address software and system level issues
• Initiates, updates, and/or approves controlled document change requests
• Performs other related tasks assigned by the supervisor
• Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Qualifications Minimum Requirements

• Bachelor's Degree STEM field
• 2-5 years System/process validation or process engineering

Preferred Qualifications

• Experience in the medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods
• Knowledge and working application of Validation Principles and guidelines and industry practice, FMEA, and Risk Analysis
• Knowledge and working application of Quality Management Systems
• Demonstrated strong analytical problem solving, team and communications/interpersonal skills
• Computer competency in MS Office
• Excellent written, technical and verbal communication skills
• Adaptable to fast-paced, dynamic work environment with ability methodically manage projects

The estimated base salary range for the Validation Engineer 2 role based in the United States of America is: $74, 900 - $112, 300. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual's qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative 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 offer opportunities to engage in social responsibility. 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 conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. 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. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.