Engineer 2, Process Development
Illumina
Summary
We are seeking a motivated and talented Process Engineer to join the Substrates Team within the Manufacturing Technology & Transfer (MTT) Group. The MTT team plays a critical role in Consumables Development and Manufacturing by developing, scaling, and deploying manufacturing processes for new products within production environments.
Job description
In this role, you will provide technical leadership for new product introductions and process development activities. You will collaborate closely with Research & Development, Quality, Manufacturing, Supply Chain, and Engineering teams to develop, transfer, and sustain robust manufacturing processes that support successful product commercialization.
Responsibilities
- Partner with R&D, Manufacturing, Supply Chain, and Quality teams to design and develop robust, high-volume manufacturing processes using Critical Parameter Management (CPM) principles.
- Design, execute, and analyze controlled experiments, including Design of Experiments (DOE), to optimize processes, improve yield and quality, and implement solutions in production environments.
- Drive product and process change management activities, including product configuration within ERP systems, to support successful product launches.
- Conduct root cause investigations using methodologies such as 8D, model-based problem solving, and statistical analysis to identify and resolve technical and compliance-related issues.
- Serve as a subject matter expert for critical-to-quality (CTQ) and critical-to-performance (CTP) process characteristics.
- Apply process engineering tools and methodologies, including FMEA, SPC, Gauge R&R, Critical Parameter Management, and Design for Manufacturability (DFM), to improve process capability and robustness.
- Lead technical project teams, drive execution of key deliverables, and identify risk mitigation strategies to achieve project milestones.
- Define technical requirements, create process documentation, and facilitate the transfer of manufacturing and quality control processes from development through scale-up and commercialization in a regulated environment.
Requirements
- Strong written and verbal communication skills, with the ability to effectively collaborate across multiple functions is required.
- Proven ability to achieve objectives in a cross-functional team environment is required.
- Excellent analytical, problem solving, and critical-thinking skills are required.
- Experience with statistics, Statistical Process Control (SPC), and Design of Experiments (DOE) is an advantage.
- Experience in high-volume manufacturing within a high-tech consumables or related industry is an advantage.
- Familiarity with product development processes and project management methodologies is an advantage.
Education and Experience
- B.S./M.S. in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science equivalent with 2+ years of relevant experience in production sustaining, process development, scale-up, and validation.
- PhD in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science with relevant experience in process development. Experience with production sustaining, process development, scale-up, and validation is an advantage.
Requirements
- Strong written and verbal communication skills, with the ability to effectively collaborate across multiple functions is required.
- Proven ability to achieve objectives in a cross-functional team environment is required.
- Excellent analytical, problem solving, and critical-thinking skills are required.
- Experience with statistics, Statistical Process Control (SPC), and Design of Experiments (DOE) is an advantage.
- Experience in high-volume manufacturing within a high-tech consumables or related industry is an advantage.
- Familiarity with product development processes and project management methodologies is an advantage.
- B.S./M.S. in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science equivalent with 2+ years of relevant experience in production sustaining, process development, scale-up, and validation.
- PhD in Chemical Engineering, Bioengineering, Biomedical Engineering, or Material Science with relevant experience in process development.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Retirement benefits
- Paid time off
- Genomics sequencing access
- Family planning
- Bonus program
- Equity
Company overview
Illumina is a global leader in genomics technology, founded in 1998 and headquartered in San Diego, California. As a pioneering biotechnology company, Illumina specializes in developing, manufacturing, and marketing integrated systems for genetic analysis, with a primary focus on DNA sequencing and array-based technologies. The company's mission is to improve human health by unlocking the power of the genome, serving customers across research, clinical, and applied markets worldwide. Illumina's innovative platforms, including the NovaSeq, HiSeq, MiSeq, and NextSeq series, have revolutionized genomic research and clinical applications, enabling breakthroughs in personalized medicine, disease research, and drug development. With over 9,000 employees across 27 countries, Illumina has established itself as the dominant force in next-generation sequencing, processing more than 90% of all DNA sequencing data globally. The company's technologies support diverse applications from cancer research and rare disease diagnosis to agricultural genomics and infectious disease surveillance, making genomic insights accessible to researchers and clinicians worldwide.