Engineer 2 - Process Development (Chemistry)
Engineer 2 - Process Development (Chemistry)
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$ 73400 - 110200
1 Vacancy
Job Description
The Process Engineer 2 is part of the sustaining technical operations engineering team who provides expertise service and support to San Diego Illumina ReagentTechnical Operations Team. The Process Engineer 2 will provide technical knowledge and support to Formulation through Fill and Packaging 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 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 .
Must be detail oriented.
Experience with standard laboratory practices
High level computer skills are . Advanced data collection (R Python shell/batch) is a plus.
Knowledge and experience of scale-up chemistry and HPLC analytical chemistry experience .
Experience with SAP or equivalent ERP system.
Understanding of pFMEA
Working knowledge and experience of manufacturing execution system (MES) is desirable.
Experience working in an ISO 13485 or FDA regulated environment 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:
Bachelors 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 To learn more visit: 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.
Employment Type
Full-Time
