Sr Engineer - Process Development

Illumina•San Diego, CA

About The Position

Illumina is seeking a driven Process Engineer to join the Manufacturing Technology & Transfer team within Global Operations. The position is part of the Reagent Development team and focuses on developing and deploying oligonucleotide manufacturing processes. The engineer partners with development teams, Quality, Production, Supply Chain, and other engineering groups to develop and transfer sustainable manufacturing processes. The role supports new product introduction and manufacturing through process development, equipment requirements, controlled experimentation, troubleshooting, process optimization, and transfer of technical knowledge into production and sustaining teams. The position operates in a GMP manufacturing context and collaborates across functions to meet project goals.

Requirements

  • Expertise with oligonucleotide processes, including synthesis, cleavage/deprotection, purification, desalting, and in-process and final quality control.
  • Expertise with relevant equipment, including synthesizers, preparative and analytical HPLCs, mass spectrometers, and UV spectrophotometers.
  • Demonstrated 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 design of experiments techniques.
  • 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 PhD with no experience, in Chemistry, Biochemistry, Chemical Engineering, or an equivalent field.

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 as needed to support project timelines.
  • Develop manufacturing processes and define technical requirements for new production equipment.
  • Author procedures and instructions for new manufacturing processes and train production operators to manufacture products in a GMP environment.
  • Troubleshoot new product and manufacturing process issues related to yield, quality, and throughput.
  • Construct and execute controlled experiments, including design of experiments (DOEs), to optimize processes and scale them.
  • Address yield and quality issues and drive implementation of solutions in production to meet project goals.
  • Analyze process test results, author reports, and provide 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 knowledge transfer into manufacturing and sustaining support teams.

Benefits

  • Variable cash program eligibility (bonus or commission).
  • Equity may be included for eligible roles.
  • Access to genomics sequencing.
  • Family planning benefits.
  • Health, dental, and vision benefits.
  • Retirement benefits.
  • Paid time off.
  • Employee Resource Groups offering career development experiences, cultural awareness, and social responsibility opportunities.
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