Job Description
Job Overview:
The Process Engineer 2 is part of the sustaining technical operations engineering team who provides expertise, service, and support to San Diego Illumina Reagent Technical Operations Team. The Process Engineer 2 will provide technical knowledge and support to Formulation through Fill, Packaging, and QC manufacturing to address sustaining issues, as well implement new products. The Process Engineer 2 will work with multi-disciplinary teams to lead design changes and process improvements for reagents for various on-market products. This individual will work in a dynamic team-oriented environment that supports multiple operations and technologies helping Illumina deliver its highly complex product pipeline in a reliable and sustainable manner.
Responsibilities:
Provide technical leadership in the production and analysis of various reagent formulations in a regulated manufacturing environment.
Analyze trends and monitor/update Manufacturing KPIs and metrics.
Perform and/or support investigation of out of specification results, product impacting issues, or nonconforming material, including sample preparation and testing.
Initiate, design, plan and execute studies to optimize production processes or troubleshoot chemistry production issues, with oversight.
Analyze test results, draft engineering reports, and make technical recommendations.
Represents and advocates for Operations’ needs in cross-functional meetings to ensure quality, continuity and efficiency of products and processes transferred to and implemented within manufacturing teams.
Work and communicate effectively with cross-functional teams to both (1) address operational sustaining needs (i.e. resolve production issues related to safety, yield, quality, and/or throughput) and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products.
Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements.
Responsible for productive cross-site and cross-functional relationship between manufacturing sites.
Plan and prioritize assigned tasks and activities with minimal guidance.
Execute tasks independently and with guidance as necessary from project lead or manager.
Influence technical decisions in own area of responsibility.
Track component COGs and associated project expenses.
Execution of manufacturing builds when needed to support Development, Pre-Production and Production orders.
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
Requirements:
Experience in process support and development in a GMP environment.
Strong analytical, problem-solving, troubleshooting, and root cause analysis skills.
Strong interpersonal, verbal, and written communication skills required.
Must be detail oriented.
High level computer skills are required. Advanced data collection (R, Python, shell/batch) is a plus.
Knowledge and experience of scale-up chemistry and HPLC analytical chemistry experience required.
Understanding of pFMEA
Working knowledge and experience of manufacturing execution system (MES) is desirable.
Experience with lean manufacturing tools and principles is a plus.
Experience with statistics, Statistical Process Control, GR&R, and DOE techniques is desirable.
Education:
Bachelor’s Degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or a related discipline and 2-3 years of relevant experience.
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.
