The Process Development Engineer 2 develops and supports manufacturing processes for consumable products, ensuring quality and compliance in biotech manufacturing environments.
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.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.
Position Summary:
The Process Development Engineer 2 serves an important role in the MTT (Manufacturing Technology and Transfer group) ensuring that the product is manufactured, transferred, and delivered at the highest quality to the customer. The individual will work cross functionally with other Departments in Consumable Development, Reagent formulation, Manufacturing, Automation, Facilities, Supply chain and Quality assurance to develop processes for new products and provide sustaining support to improve processes for existing products. The MTT group works as an integral part of our Consumables Development and Manufacturing teams and is tasked with developing and deploying consumables manufacturing processes within our production environments.
Position Responsibilities:
- Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products
- Represent Operations needs on development teams for effective transfer of products into manufacturing
- Define technical requirements for manufacturing processes and new production equipment
- Support qualification of new process, system, tools, and equipment
- Ensure process system and equipment are in compliance with company quality system and regulatory requirements
- Develop understanding of CPM (critical parameter management), construct and execute controlled experiments and including DOEs to optimize processes, product, address yield and quality issues and drive implementation of solutions into a production environment to meet project goals
- Analyze process test results, issue reports, and make technical recommendations to improve product and process quality
- Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
- Participate in advanced failure analysis, process or issue technical deep dive, characterization and First Principles understanding to implement corrective actions for product quality concerns and/or issues during manufacturing and NPI ramp towards long term preventive and corrective measures
- Utilize expertise in 6-sigma, DFSS, 8D, DMAIC to solve issues that arise during product and process development phases of new product introductions
- Perform feasibility and/or characterization studies for availability, yield, and product quality
- Proactively drive change management associated to implementation of identified deliverables
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
- Possess good understanding of manufacturing process and regulated biotech or medical devices manufacturing environment
- Capable of defining test plans for components, materials, systems and processes
- Experience with using engineering methodology, tools and software packages (eg R, Python, JMP, etc)
- Competent in high-level problem solving and reasoning skills required. Well versed in FMEA, DMAIC and 8D methodology
- Knowledge in product & process feasibility study, line validation, qualification, and optimization to production
- Excellent Analytical, and Problem Solving skills
- Good understanding of Quality Assurance and Statistical Process Control
- Excellent team player, interpersonal and communication skills
- Well-developed documentation, presentation and technical report writing skills
- Able to work well under stress, both internally and across functions, and perform multitasking
- Demonstrated ability to accomplish goals, while working across departments, is required
Education and Experience:
- B.S./M.S. in Mechanical, Chemical Engineering, Bioengineering, Manufacturing Engineering, or Material Science with at least 2+ years of relevant experience in production support/sustaining and/or process definition and development, design & scale-up
- PhD in Mechanical, Chemical Engineering, Bioengineering, Materials Science with at least 0 years of relevant experience in production support/sustaining and/or process definition and development, design & scale-up
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.
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