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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.
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 global cross functional teams to effectively support progress towards group and platform goals.
Illumina, Inc. is an American company. Incorporated on April 1, 1998, Illumina develops, manufactures, and markets integrated systems for the analysis of genetic variation and biological function. The company provides a line of products and services that serves the sequencing, genotyping and gene expression, and proteomics markets. Its headquarters are located in San Diego, California.
Job ID: 145449117