Senior Process Engineer, Oligonucleotide Manufacturing

Illumina

San Diego (CA)

On-site

USD 98,000 - 148,000

Full time

24 hours ago
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Benefits offered by this job

Genomics sequencing access
Family planning benefits
Health/dental/vision insurance
Retirement benefits
Paid time off

Job summary

Illumina is seeking driven Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. You will develop and deploy oligonucleotide manufacturing processes and partner with development, Quality, Production, and Supply Chain teams in a GMP setting.

Responsibilities include executing feasibility builds, creating production equipment requirements, authoring procedures, and training operators to manufacture products.

Qualifications

  • Minimum 5 years oligonucleotide experience with a Bachelor’s degree; or 3+ years with a Master’s; or PhD without chemistry/biochemistry/chemical engineering experience.
  • Experience with cGMP and 21 CFR Part 11 in an FDA-regulated environment.
  • Strong cross-functional collaboration and communication skills.
  • Experience with DOE and Statistical Process Control.

Responsibilities

  • Execute feasibility and development oligonucleotide builds to support project timelines.
  • Define technical requirements for new production equipment and processes.
  • Author procedures and train operators for GMP manufacturing.
  • Troubleshoot yield, quality and throughput issues in production.
  • Conduct DOE-based experiments to optimize processes and scale for production.
  • Analyze results, write reports and propose process improvements.
  • Collaborate with Product Development, Supply Chain, Manufacturing, Quality, EHS and Facilities.
  • Ensure knowledge transfer to manufacturing and sustaining teams.

Skills

Oligonucleotide synthesis
Oligonucleotide QC
HPLC
DOE
cGMP
21 CFR 11
Statistical Process Control
Cross-functional collaboration

Education

Bachelor’s degree in Chemistry/Biochemistry/Chemical Engineering

Tools

Synthesis equipment
HPLC systems
MS instruments
UV spectrometers

Job description

Illumina is seeking driven Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. You will develop and deploy oligonucleotide manufacturing processes and partner with development, Quality, Production, and Supply Chain teams in a GMP setting.

Responsibilities include executing feasibility builds, creating production equipment requirements, authoring procedures, and training operators to manufacture products.

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