Engineer 2, Process Development

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. Position Summary We are looking for driven, motivated & innovative New Product Introduction Process Engineer to join our growing New Products Introduction (NPI) team to support new process development and improvements in high volume manufacturing environment. As an NPI Process Development Engineer, you will work as part of a multi-disciplinary team to develop processes and technologies that manufacture Array, Library Preparation and Sequencing consumables. This position will lead on-market transfers, process improvements, failure investigations and participate in product development projects. This role will be partnered with cross-functional departments such as R&D, Manufacturing, Quality and Supply Chain. Position Responsibilities · Participate in consumables reagent new products introduction and technology transfers for Array and Sequencing products and processes. · Participate in process definition, improvement, design, development and quality test activities for development and subsequently scaling up and optimizing new products to production. · Define and develop technical requirements and procedures for manufacturing to process products. · Construct and execute controlled experiments to address yield and quality issues and drives implementation of solutions in product development process for pilot and scale up. · Participate in complex technical issues to establish improvement solutions to correct or prevent recurrence of product and process failure. · Troubleshoot process development and product transfer issues related to yield, quality, and throughput. · Support development of key strategic process development program, complete design and projects within schedule, budget and quality constraints. · Present results and data to collaborators, extended teams on a regular basis and senior management. · Manage and strategize change controls and assessments according to cGMP requirements. · Manage non-conformances, deviations and root cause analyses according to cGMP requirements. 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. Position Requirements · Bachelor’s Degree in Chemical Engineering, Chemistry, Material Science or equivalent field. · Minimum 2 years of related experience in process or product development and project management required. · Experience in the biotech/pharmaceutical industries is desirable. · High degree of initiative and ownership while working with several different departments in a fast-paced environment is desired. · Excellent organizational skills and attention to detail required. · Proven track record in rational, hypothesis based experimental design, execution and data analysis is desired. · Demonstrated ability to work independently. · Ability to effectively troubleshoot and propose next steps. · Able to apply Statistical Process Control knowledge and DOE techniques. · Able to analyze data and make logical and rational conclusions. · Excellent verbal/written communication skills. · A self-starter, positive, ability to work with ambiguous requirements and driven with a “can do” attitude. · Collaborative, open, team player; able to rapidly integrate into ... (truncated, view full listing at source)