Engineer 2 - Process Development • Manufacturing Technology & Transfer Dept

Responsibilities:

Participate in consumable product development, manufacturing process development, process and product improvements, and other activities in the making of consumable products to sequence genomes

Represent Operations needs on development teams for effective transfer of products into manufacturing

Define technical requirements for manufacturing processes and new production equipment

Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment

Design, 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 products

Troubleshoot new product and manufacturing process issues related to yield, quality and throughput

Provide technical oversight, coordination and execution of development and pilot plant builds within the Pilot Plant production area supporting multiple projects and initiatives

Develop 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 goals

Analyze process test results, issue reports and make technical recommendations to improve product and process quality

Utilize expertise in 6-sigma, DFSS, 8D, DMAIC to solve issues that arise during product and process development phases of new product introductions

Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality teams to enable operations for both launch and high-volume manufacturing

Ensure successful transfer of knowledge into manufacturing and the sustaining support teams

Requirements:

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 validation

Experience with Statistics, Statistical Process Control and DOE techniques is a plus, High level problem solving, and reasoning skills required

Experience with cGMP, 21CFR820, ISO 13485 and ISO 14971 supporting manufacturing in an FDA regulated environment is preferred

Effective communication skills both verbal and written, analytical and organizational skills to manage competing project priorities

Experience with high volume production in a high tech, high volume consumables industry is a plus

Experience with product development processes and project management is a plus

Demonstrated ability to accomplish goals while working across departments is required

Knowledge of or experience with lyophilization cycle development, excipient and formulation development, lyophilization manufacturing sustaining and/or support is highly desirable

Knowledge of or experience with liquid handling and automation such as Hamilton Robotics or Tecan and/or support of processes is highly desirable

Education 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 engineering

The 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 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.