Engineer 1 - Process Development

Illumina • San Diego, CA

10h

About The Position

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.

Requirements

• Experience with some and ideally 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
• Experience with Statistics, Statistical Process Control and DOE techniques is a plus
• 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
• B.S. or M.S. in Chemistry, Biochemistry, Chemical Engineering, or equivalent, with 0-3 years of relevant industry experience in oligonucleotide manufacturing/support, process development, scale-up, and process improvement

Responsibilities

• Execute feasibility and development oligonucleotide builds as necessary to support various projects timelines
• 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
• Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
• Develop understanding of CPM (critical parameter management); 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, contribute to 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 to enable operations for both launch and final scale manufacturing
• Ensure successful transfer of knowledge into manufacturing and the sustaining support teams
• 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

• Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package.
• We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
• We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission.
• Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics.
• We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race.
• We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees