Engineer 2, Process Development jobs in United States
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Illumina · 11 hours ago

Engineer 2, Process Development

Illumina is expanding access to genomic technology to realize health equity for billions of people. They are seeking a motivated Process Development Engineer II to provide technical expertise to QC and manufacturing teams, focusing on method and process development, troubleshooting, and continuous process improvement.

BiotechnologyGeneticsHealth CareMedical
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Responsibilities

Lead troubleshooting and resolution of QC and manufacturing issues impacting yield, quality, throughput, product performance, and FPY, identify root cause, define corrective/preventive actions, and drive closure, escalating high risk and complex cases as needed
Investigate and disposition of non-conforming material, using data-driven justification and risk assessment
Identify and support continuous improvement projects (yield, cost, throughput, automation, scrap reduction, workflow optimization)
Contribute to project business cases, financial models, cost/benefit analyses, and scenario planning to influence decisions and prioritize initiatives
Represent Mfg and QC in NPI transfer activities, defining requirements, building process maps, setting specifications, and ensuring production readiness
Design and conduct controlled experiments including capability studies, GRR, and statistical analyses to optimize processes and sustain performance
Define requirements and lead validation planning, execution, documentation, and reporting for methods, equipment, and process changes
Work cross-functionally with R&D, Mfg/QC, quality, validation and customer support team
Develop and maintain SPC monitoring, control charts, trending, and data visualization to proactive detect process and product risks
Analyze complex data sets using advanced statistical tools (JMP, R, Python, SQL)

Qualification

Process DevelopmentData AnalysisStatistical MethodsSequencing TechnologyRegulated EnvironmentsContinuous ImprovementBusiness SystemsProject ManagementCommunication SkillsProblem-Solving SkillsTeam Collaboration

Required

B.S./M.S. in Chemical Engineering, Bioengineering, Biochemical Engineering, Molecular Biology or Manufacturing Engineering, with 3-5 years of relevant experience in a production support and/or process development, design, or scale-up role
PhD in Chemical Engineering, Bioengineering, Biochemical Engineering, Molecular Biology or Manufacturing Engineering, with 0-2 years of relevant experience
Strong understanding of sequencing technology, library prep chemistry, analytical testing, QC workflows, production processes, and process impacts on product functional response
Demonstrated ability to support complex technical investigations, and problem-solving skills
Expert in data analysis, statistical methods, DOE, capability studies, spec setting, and control charting
Demonstrated ability to define project goals, scope, resources, schedules, milestones, and stakeholder engagement plans
Experienced with business systems such as SAP, MES/LIMS, NC systems, Teamcenter, ETQ, validation, and system integrations

Preferred

Experience in ISO13485, FDA, GMP, or similarly regulated environments
Familiar scripting languages (Python, R, SQL)
Strong communication and presentation skills
High accountability, adaptability, and initiative
Ability to build trust, influence stakeholders, and drive alignment across functions and levels

Benefits

Access to genomics sequencing
Family planning
Health/dental/vision
Retirement benefits
Paid time off

Company

Illumina

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Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.

Funding

Current Stage
Public Company
Total Funding
$1.28B
Key Investors
Bank of America
2024-09-06Post Ipo Debt· $500M
2023-01-04Post Ipo Debt· $750M
2000-07-28IPO

Leadership Team

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Steven Barnard
Chief Technology Officer, Head of Research & Product Development
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Jenny Lei Zheng
SVP & GM of Greater China
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Company data provided by crunchbase