Engineer - Process Development • Manufacturing Technology & Transfer Dept

Position: Engineer 2 - Process Development • Manufacturing Technology & Transfer Dept
## 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.##
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* Position Summary:

** We are looking for driven, talented Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. This position is an integral part of our Reagent Pilot Plant and Manufacturing teams and is tasked with developing and deploying reagent formulation, fill and assembly processes for internal and external production environments. The individual will provide technical leadership to new product introduction, partner closely with development teams, Quality, Production, Supply Chain, and other engineering groups to develop, transfer and sustain manufacturing processes.
** Responsibilities:
*** Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products to sequence genomes
* Represent Operations needs on development teams for effective transfer of products into manufacturing
* Define technical requirements for manufacturing processes and new production equipment
* Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
* Design, develop and source production equipment from vendors and OEM’s, work cross functionally with EHS and Facilities to establish safe production processes to enable manufacturing of consumable products
* Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
* Provide technical oversight, coordination and execution of development and pilot plant builds within the Pilot Plant production area supporting multiple projects and initiatives
* Develop understanding of CPM (critical parameter management), construct and execute controlled experiments and including DOE's to optimize processes, 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
* Utilize expertise in 6-sigma, DFSS, 8D, DMAIC to solve issues that arise during product and process development phases of new product introductions
* Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality teams to enable operations for both launch and high-volume manufacturing
* Ensure successful transfer of knowledge into manufacturing and the sustaining support teams
** Requirements:
*** Work experience in production, pilot plant, and/or process development following GMP best work practices and techniques is required.
* Experience with product development processes, design transfer and process and equipment validation
* Experience with Statistics, Statistical Process Control and DOE techniques is a plus, High level problem solving, and reasoning skills required
* Experience with cGMP, 21

CFR
820, ISO 13485 and ISO 14971 supporting manufacturing in an FDA regulated environment is preferred
* Effective communication skills both verbal and written, analytical and organizational skills to manage competing project priorities
* Experience with high volume production in a high tech, high volume consumables industry is a plus
* Experience with product development processes and project management is a plus
* Demonstrated ability to accomplish goals while working across departments is required
* Knowledge of or experience with lyophilization cycle development, excipient and formulation development, lyophilization manufacturing sustaining and/or support is highly desirable
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