Engineer 2 - Process Development • Manufacturing Technology & Transfer Dept

Illumina; San Diego (CA); On-site; USD 83,000 - 124,000; Full time

Benefits offered by this job

Health benefits

Equity plans

Bonus opportunities

Job summary

Illumina in San Diego seeks a driven Process Engineer to join Manufacturing Technology & Transfer. You will develop and transfer reagent formulation, fill and assembly processes for internal and external production, leading cross-functional teams to ensure smooth technology transfer to manufacturing.

You will design controlled experiments, apply 6-Sigma/DOE methods, and mentor operators in GMP settings. The role requires strong collaboration with Product Development, Quality and Supply Chain.

Qualifications

• Bachelor's degree in mechanical/chemical/materials or bioengineering with 2–4 years of process development experience.
• Experience transferring processes into GMP manufacturing and supporting scale-up.
• Familiarity with DOE, SPC and quality tools to drive process improvement.

Responsibilities

• Drive development and transfer of reagent formulation, fill and assembly processes.
• Lead cross-functional teams for technology transfer to manufacturing and external production.
• Define manufacturing requirements and qualification plans for new equipment.
• Develop DOE experiments to optimize yield and quality in GMP environments.
• Troubleshoot process issues affecting throughput and product quality.

Skills

GMP experience

Process development

6-Sigma/DOE

Statistics/ SPC

Cross-functional teamwork

Education

B.S./M.S./PhD in Mechanical/Chemical/MSE/Bioengineering

Tools

Hamilton Robotics

Tecan

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 Engineers to join the Manufacturing Technology & Transfer team within Global Operations. This position is an integral part of our Reagent Pilot Plant and Manufacturing teams and is tasked with developing and deploying reagent formulation, fill and assembly processes for internal and external production environments. The individual will provide technical leadership to new product introduction, partner closely with development teams, Quality, Production, Supply Chain, and other engineering groups to develop, transfer and sustain manufacturing processes.Responsibilities:Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products to sequence genomesRepresent Operations needs on development teams for effective transfer of products into manufacturingDefine technical requirements for manufacturing processes and new production equipmentAuthor procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environmentDesign, develop and source production equipment from vendors and OEM’s, work cross functionally with EHS and Facilities to establish safe production processes to enable manufacturing of consumable productsTroubleshoot new product and manufacturing process issues related to yield, quality and throughputProvide technical oversight, coordination and execution of development and pilot plant builds within the Pilot Plant production area supporting multiple projects and initiativesDevelop understanding of CPM (critical parameter management), construct and execute controlled experiments and including DOE's to optimize processes, address yield and quality issues and drive implementation of solutions into a production environment to meet project goalsAnalyze process test results, issue reports and make technical recommendations to improve product and process qualityUtilize expertise in 6-sigma, DFSS, 8D, DMAIC to solve issues that arise during product and process development phases of new product introductionsWork cross functionally with Product Development, Supply Chain, Manufacturing, Quality teams to enable operations for both launch and high-volume manufacturingEnsure successful transfer of knowledge into manufacturing and the sustaining support teamsRequirements:Work experience in production, pilot plant, and/or process development following GMP best work practices and techniques is required.Experience with product development processes, design transfer and process and equipment validationExperience with Statistics, Statistical Process Control and DOE techniques is a plus, High level problem solving, and reasoning skills requiredExperience with cGMP, 21CFR820, ISO 13485 and ISO 14971 supporting manufacturing in an FDA regulated environment is preferredEffective communication skills both verbal and written, analytical and organizational skills to manage competing project prioritiesExperience with high volume production in a high tech, high volume consumables industry is a plusExperience with product development processes and project management is a plusDemonstrated ability to accomplish goals while working across departments is requiredKnowledge of or experience with lyophilization cycle development, excipient and formulation development, lyophilization manufacturing sustaining and/or support is highly desirableKnowledge of or experience with liquid handling and automation such as Hamilton Robotics or Tecan and/or support of processes is highly desirableEducation and Experience:B.S./M.S./PhD in Mechanical Engineering, Chemical Engineering, Material Science, or Bioengineering, with 2-4 years of relevant experience in process development, scale-up, process improvement, quality engineeringThe estimated base salary range for the Engineer 2 - Process Development • Manufacturing Technology & Transfer Dept 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.