Engineer 2, Process Development

Illumina • San Diego, CA

2d

About The Position

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. We are seeking a motivated and technically strong Process Development Engineer II to join the reagent MTO team supporting Reagent Operation. This role provides hands-on technical expertise to QC and manufacturing teams across NPI transfer, method and process development, troubleshooting, and continuous process improvement. The Process Development Engineer II will contribute to technical investigations, validation activities, and data-driven decision-making to ensure robust, compliant, and efficient QC and manufacturing operations. This position requires the ability to execute multiple workstreams in parallel under moderate timelines while applying sound scientific judgment and structured problem-solving. The engineer will partner closely with Manufacturing, Quality, Validation, and MTT to support nonconformance investigations, NPI transfers, and sustaining initiatives. While complex and high-risk issues may be escalated with guidance, this role is expected to independently drive well-defined technical work, contribute to cross-functional projects, and continuously build technical depth in genomics, sequencing technologies, and QC workflows. The ideal candidate brings a strong foundation in process development or production support within regulated environments, demonstrates proficiency in data analysis and statistical methods, and communicates effectively across functions. This role offers meaningful opportunities to expand technical ownership, influence process improvements, and develop toward senior technical or leadership paths.

Requirements

• 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.
• Strong communication and presentation skills.
• High accountability, adaptability, and initiative.
• Ability to build trust, influence stakeholders, and drive alignment across functions and levels.

Nice To Haves

• Experience in ISO13485, FDA, GMP, or similarly regulated environments preferred.
• Familiar scripting languages (Python, R, SQL) preferred.

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)

Benefits

• Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package.
• We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees