Sr Engineer - Process Development

Responsibilities

• Execute feasibility and development oligonucleotide builds as necessary to support various projects timelines
• Ideate and create manufacturing processes and define technical requirements for new production equipment
• Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
• Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
• Construct and execute controlled experiments including DOE's to optimize processes and scale; address yield/quality issues and drive implementation of solutions into a production environment to meet project goals
• Analyze process test results, author reports and inform technical recommendations to improve product and process quality
• Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality, EHS and Facilities teams by representing Oligo MTT on NPI core teams
• Ensure successful transfer of knowledge into manufacturing and the sustaining support teams

Requirements

• Expertise with all oligonucleotide processes (synthesis, cleavage/deprotection, purification, desalting, and in-process and final QC) and equipment (synthesizers, preparative HPLCs, analytical HPLCs, MSs, UV Specs, etc)
• Experience with liquid handlers and ERP systems is a plus
• Demonstrated ability to accomplish goals while working across departments
• Effective communication (both verbal and written) and organizational skills to manage competing project priorities
• Expertise with Statistics, Statistical Process Control and DOE techniques
• Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment is preferred
• Experience with high volume production in a high tech consumables industry is a plus
• Experience with product development processes and project management is a plus
• Education / Experience:
• Typically requires a minimum of 5 years of related oligonucleotide experience with a Bachelor's degree; or 3+ years and a Master's degree; or a PhD without experience in Chemistry, Biochemistry, Chemical Engineering or equivalent
• 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.

Benefits

Additional Information

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, talented Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. This position is an integral part of our Reagent Development team and is tasked with developing and deploying oligonucleotide manufacturing processes. The individual will partner closely with development teams, Quality, Production, Supply Chain, and other engineering groups to develop and transfer sustainable manufacturing processes.

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