Illumina

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.

Key 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)

Education & Experience:

• 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.

Technical Expertise:

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

The estimated base salary range for the Engineer 2, Process Development role based in the United States of America is: $82,500 - $123,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. 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.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.