Engineer - Process Development; Chemistry

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.

The Process Engineer 2 is part of the sustaining technical operations engineering team who provides expertise , service, and support to San Diego Illumina Reagent Technical Operations Team . The Process Engineer 2 will provide technical knowledge and support to Formulation through Fill, Packaging, and QC manufacturing to address sustaining issues, as well implement new products. The Process Engineer 2 will work with multi-disciplinary teams to lead design changes and process improvements for reagents for various on-market products .

This individual will work in a dynamic team-oriented environment that supports multiple operations and technologies helping Illumina deliver its highly complex product pipeline in a reliable and sustainable manner .

Responsibilities:

• Provide technical leadership in the production and analysis of various reagent formulations in a regulated manufacturing environment.

• Analyze trends and monitor /update Manufacturing KPIs and metrics.

• Perform and/or support investigation of out of specification results, product impacting issues, or nonconforming materia l, including sample preparation and testing.

• Initiate, design, plan and execute studies to optimize production processes or troubleshoot chemistry production issues , with oversight.

• Analyze test results, draft engineering reports, and make technical recommendations .

• Represents and advocates for Operations’ needs in cross-functional meetings to ensure quality, continuity and efficiency of products and processes transferred to and implemented within manufacturing teams.

• Work and communicate effectively with cross-functional teams to both (1) address operational sustaining needs ( i.e. resolve production issues related to safety, yield, quality, and/or throughput) and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products.

• Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements.

• Responsible for productive cross-site and cross-functional relationship between manufacturing sites.

• Plan and prioritize assigned tasks and activities with minimal guidance.

• Execute tasks independently and with guidance as necessary from project lead or manager.

• Influence technical decisions in own area of responsibility.

• Track component COGs and associated project expenses.

• Execution of manufacturing builds when needed to support Development, Pre-Production and Production orders.

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

Requirements:

• Experience in process support and development in a GMP environment.

• Strong analytical, problem-solving, troubleshooting, and root cause analysis skills.

• Strong interpersonal, verbal, and written communication skills required .

• Must be detail oriented.

• High level computer skills are required . Advanced data collection (R, Python, shell/batch ) is a plus.

• Knowledge and experience of scale-up chemistry and HPLC analytical chemistry experience required .

• Understanding of pF MEA

• Working knowledge and experience of manufacturing execution system (MES) is desirable.

• Experience with lean manufacturing tools and principles is a plus.

• Experience with statistics, Statistical Process Control, GR&R, and DOE techniques is desirable.

Education:

• Bachelor ’ s Degree in Chemistry , Biochemistry, Molecular Biology, Chemical Engineering, or a…