Validation Engineer 2

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. 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 ... (truncated, view full listing at source)