Sr Engineer - Process Development

Illumina•San Diego, CA

2d•$98,400 - $147,600

About The Position

Illumina is seeking a Process Engineer for its Manufacturing Technology & Transfer team within Global Operations. The role is part of the Reagent Development team and focuses on developing and deploying oligonucleotide manufacturing processes. The engineer will work with development teams, Quality, Production, Supply Chain, and other engineering groups to develop and transfer sustainable manufacturing processes. The position supports new product introduction and manufacturing through process development, equipment definition, controlled experimentation, troubleshooting, documentation, operator training, and knowledge transfer. It also represents Oligo MTT on cross-functional NPI teams and supports the transfer of processes to manufacturing and sustaining teams. The estimated U.S. base salary range is $98,400–$147,600. Employees are eligible for a variable cash program, and eligible roles may receive equity. Benefits include access to genomics sequencing, family planning, health, dental and vision coverage, retirement benefits, and paid time off. The role is not eligible for visa sponsorship.

Requirements

Typically, at least 5 years of related oligonucleotide experience with a bachelor's degree; or 3 or more years with a master's degree; or a Ph.D. with no experience requirement, in Chemistry, Biochemistry, Chemical Engineering, or an equivalent field.
Expertise in oligonucleotide synthesis, cleavage/deprotection, purification, desalting, and in-process and final QC.
Expertise with oligonucleotide manufacturing equipment, including synthesizers, preparative HPLCs, analytical HPLCs, mass spectrometers, and UV spectrophotometers.
Ability to accomplish goals while working across departments.
Effective verbal and written communication and organizational skills to manage competing project priorities.
Expertise in statistics, Statistical Process Control, and DOE techniques.

Nice To Haves

Experience with liquid handlers and ERP systems.
Experience with cGMP, 21 CFR Part 11, and supporting manufacturing in an FDA-regulated environment.
Experience with high-volume production in a high-tech consumables industry.
Experience with product development processes and project management.

Responsibilities

Execute feasibility and development oligonucleotide builds to support project timelines.
Create manufacturing processes and define technical requirements for new production equipment.
Write 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.
Design and execute controlled experiments, including DOE studies, to optimize and scale processes, resolve yield and quality issues, and implement solutions in production.
Analyze process test results, author reports, and provide technical recommendations to improve product and process quality.
Collaborate with Product Development, Supply Chain, Manufacturing, Quality, EHS, and Facilities teams, representing Oligo MTT on NPI core teams.
Ensure successful knowledge transfer to manufacturing and sustaining support teams.