Process Engineer 2 - Process Development

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.

Position 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.

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.

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. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. 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 [email protected]. 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.