QC Engineer I
IlluminaAbout the role
We are looking for a driven and talented QC Engineer to join our QC Technical Operations (QCTO) group supporting Reagent Quality Control. This team provides technical expertise to the Reagent QC manufacturing team in the areas of assay transfer, implementation, and troubleshooting, technical product performance investigations, process improvement, and collaboration with the manufacturing team to implement strategic initiatives.
The scientific candidate must be able to deliver multiple programs in parallel and under aggressive timelines. This position will be a key business partner in managing the quality and manufacturing relationship, which includes auditing, guidance on gap/risk closure, and meeting business and regulatory obligations with a high degree of integrity. The ideal candidate will have experience with and knowledge of Illumina Assays and sequencing technology, or a strong understanding of genomics.
Responsibilities:
Learn and understand the applicable technology and engage in technical discussions as subject matter expert.
Perform and/or support investigation of out of specification results or nonconforming material, including sample preparation and testing.
Initiate, design, plan and execute scientific studies to optimize production processes or troubleshoot chemistry production issues, with oversight.
Must be able to recognize potential problems, understand and troubleshoot issues.
Work with broader team to define specifications, critical parameters, test plans, etc.
Develop test plans/protocols and draft reports to document scientific studies.
Independently plan, manage, and prioritize tasks/projects, track progress toward project goals, and provides periodic updates to core team.
Analyze test results, draft engineering reports, and make technical recommendations.
Implement changes on existing products based on studies.
Analysis of complex/large data sets.
Present and communicate results to colleagues
Be both a strong individual contributor as well as a collaborative team member.
Work and communicate effectively within a cross-functional project team.
An ability to be flexible in a fast-paced and dynamic environment.
Representing the function on project team for new products and processes
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:
Demonstrated investigative and troubleshooting skills
Utilizes process driven approach to experimental design and troubleshooting, including understanding of DOE and statistical analysis.
Advanced data collection (R, Python, shell/batch) and ability to summarize results.
Proficient at JMP, Tableau, or other data analysis tool
Good verbal/written communication and interpersonal skills.
HPLC analytical chemistry experience considered a plus
Detail oriented with excellent laboratory, experimental, computational skills
Technically sound; show potential for technical proficiency and scientific creativity
Good scientific writing skills required
Experienced in working in a collaborative and fast-paced research laboratory environment is highly desired
Understanding of pFMEA considered a plus
Lean six sigma certification considered a plus
Education:
B.S./M.S. in Chemical Engineering, Bioengineering, Biochemical Engineering, Molecular Biology, Biochemistry, Materials Science, Electrical Engineering or Manufacturing Engineering, or a related discipline and 0-3 years of relevant experience.
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