Engineer 2 - Process Development

Illumina; Northern, San Diego (KY, CA); Hybrid; USD 83,000 - 124,000; Full time

Job summary

Illumina is seeking a driven Process Engineer to join the Reagent Development Services within the Manufacturing Technology Transfer group. You will develop and transfer consumable manufacturing processes for sequencing technologies, work across Product Development, Supply Chain, Manufacturing and Quality, and implement DOE-driven improvements in a GMP environment.

The role requires strong molecular biology and analytical skills, experience with surface chemistry, and the ability to lead

Qualifications

• Experience in medical device/biotech/pharma or semiconductor industries desirable.
• Strong molecular biology/biochemistry knowledge.
• Experience with surface chemistry and protein/oligo characterization preferred.
• Hands-on experience with organic synthesis and materials synthesis techniques.
• Experience with nanoparticles and oligos preferred.
• Excellent communication and organizational skills.

Responsibilities

• Participate in consumable product development and manufacturing process development.
• Collaborate cross-functionally with Product Development, Supply Chain, Manufacturing and Quality to scale processes.
• Perform DOEs for particle characterization and formulation.
• Perform plate-based assays such as binding assays, fluorescent, FRET, DLS, etc.
• Perform high complexity molecular testing including PCR, real-time PCR and DNA sequencing.
• Define technical requirements for manufacturing processes and new production equipment.
• Author procedures and instructions for new manufacturing processes and train production operators in GMP.
• Troubleshoot production line issues to improve yield and throughput.

Skills

Molecular biology

Biochemistry

Analytical skills

Communication skills

Problem solving

DOE techniques

Statistical Process Control

PCR

Real-time PCR

DNA sequencing

Education

BS/MS/PhD in Biotechnology/Biochemistry/BME/ChE/related

Tools

PCR

Real-time PCR

DNA sequencing

DOE methods

Job description

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 looking for driven, talented Process Engineer to join Reagent Development Services team in the Manufacturing Technology Transfer (MTT) group. The MTT group works as an integral part of our Consumables Development and Manufacturing process and is tasked with developing and deploying consumables manufacturing processes of both new and existing products within our production environments. **Responsibilities:*** Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products used in Illumina’s sequencing and Array technology* Work cross functionally with Product development, Supply chain, Manufacturing and Quality to develop processes for new products and improve processes of existing products* Perform DOEs for particle characterization and particle formulation.* Perform plate based assays such as binding assays, fluorescent, FRET, DLS, etc* Perform high complexity molecular testing using a variety of molecular biological methods including PCR, real-time PCR and DNA sequencing including sequencing analysis* Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals* Define technical requirements for manufacturing processes and new production equipment* Work on teams to develop and transfer new processes/products to production and enhance their robustness* Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment* Represent Operations needs on development teams for effective transfer of products into manufacturing* Troubleshoot production line issues related to yield, quality and throughput* Analyze process test results, issue reports and make technical recommendations* Execution of manufacturing builds when needed to support Development, Pre-Production and Production orders**Requirements:*** Work experience in the medical device, biotech, pharmaceutical or semiconductor industries is desirable* Strong background and working knowledge of molecular biology/biochemistry principles and techniques.* Experience with surface chemistry and protein/oligo characterization techniques preferred* Hands-on experience with organic synthesis and materials synthesis techniques in a laboratory setting* Experience with nanoparticles and oligos preferred* Effective communication skills both verbal and written, analytical and organizational skills to manage different priorities* High level problem solving, and reasoning skills required* Experience with statistics, Statistical Process Control and DOE techniques is a plus* Experience with high volume production in a high-tech, high-volume consumables industry is a plus* Experience with lean Six Sigma is a plus* Experience with product development processes and project management is a plus* Good interdepartmental communication skills and documentation skills are required* Demonstrated ability to accomplish goals while working across departments is required* Ability to work independently and collaborate* Adhere strictly to lab cleanliness protocols, ensuring routine cleanup of bench spaces, proper chemical disposal, and glass washing after daily operations.**Education and Experience:**BS/MS/PhD in Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering Materials Science or related field with 2-5 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation### 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 [e-mail]. 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.