Engineer , Process Development

Position: 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:

The Process Development Engineer 2 serves an important role in the MTT (Manufacturing Technology and Transfer group) ensuring that the product is manufactured, transferred, and delivered at the highest quality to the customer. The individual will work cross functionally with other Departments in Consumable Development, Reagent formulation, Manufacturing, Automation, Facilities, Supply chain and Quality assurance to develop processes for new products and provide sustaining support to improve processes for existing products.

The MTT group works as an integral part of our Consumables Development and Manufacturing teams and is tasked with developing and deploying consumables manufacturing processes within our production environments.

Position Responsibilities:

* Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products

* Represent Operations needs on development teams for effective transfer of products into manufacturing

* Define technical requirements for manufacturing processes and new production equipment

* Support qualification of new process, system, tools, and equipment

* Ensure process system and equipment are in compliance with company quality system and regulatory requirements

* Develop understanding of CPM (critical parameter management), construct and execute controlled experiments and including DOEs to optimize processes, product, address yield and quality issues and drive implementation of solutions into a production environment to meet project goals

* Analyze process test results, issue reports, and make technical recommendations to improve product and process quality

* Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment

* Participate in advanced failure analysis, process or issue technical deep dive, characterization and First Principles understanding to implement corrective actions for product quality concerns and/or issues during manufacturing and NPI ramp towards long term preventive and corrective measures

* Utilize expertise in 6-sigma, DFSS, 8D, DMAIC to solve issues that arise during product and process development phases of new product introductions

* Perform feasibility and/or characterization studies for availability, yield, and product quality

* Proactively drive change management associated to implementation of identified deliverables

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 :

* Possess good understanding of manufacturing process and regulated biotech or medical devices manufacturing environment

* Capable of defining test plans for components, materials, systems and processes

* Experience with using engineering methodology, tools and software packages (eg R, Python, JMP, etc)

* Competent in high-level problem solving and reasoning skills required. Well versed in FMEA, DMAIC and 8D methodology

* Knowledge in product & process feasibility study, line validation, qualification, and optimization to production

* Excellent Analytical, and Problem Solving skills

* Good understanding of Quality Assurance and Statistical Process Control

* Excellent team player, interpersonal and communication skills

* Well-developed documentation,…