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Senior Process Development Engineer

Company: Illumina
Location: San Diego
Posted on: September 14, 2020

Job Description:

We are looking for a technical expert for our Consumables Process Development and Transfer (cPDT) group. The cPDT group works as an integral part of our Consumables Manufacturing process and is tasked with new product introduction and increasing quality and yield within our high-volume production environments.

This individual will be primarily accountable for process development and transfer to Operations of RUO and IVD library preparation, sequencing, and micro-array assay products. The role ensured best-in-class product quality and optimized cost of goods through proactive integration of risk-based design requirements, performance testing controls, and manufacturing strategies into the product development process. Additionally, this person will lead as appropriate enhancement of on-market products and enhance/develop risk-based design and transfer processes within cPDT.

This position for the Operation's team will enable the development of Illumina's core technologies and applications in one of the most technically innovative spaces in industry. The ideal candidate will have experience in diagnostic process development to ensure and enable the transfer, launch, and on market support of complex clinical diagnostics.

Responsibilities:


  • Lead and conduct laboratory work and experiments per assigned responsibilities.
  • Establish process requirements to meet product specifications.
  • Collaborate and guide new product introduction teams throughout the stages of product development process (PDP) in order to:


    • Act as a liaison between development and manufacturing teams.
    • Lead and guide the construct and execution of controlled experiments (including DOEs, gauge R&R studies) to develop/optimize manufacturing ready production workflows or test methods.
    • Evaluate manufacturing assessment and/or develop new manufacturing processes for new products or improvements
    • Provide technical oversight and coordination of development and pilot lot builds within the Pilot Plant production area supporting multiple projects and initiatives
    • Help develop, review and execute analytical test methods to support process development activities, process scale up studies, change evaluations, and other Pilot Plant related activities.
    • Support product characterization activities and method development activities as needed, including recommending materials for reliable performance (material compatibility and availability) and manufacturing scalability
    • Ensure successful transfer of knowledge into manufacturing and the sustaining support teams
    • Monitor, trend and analyze results from development and pilot lots during the NPI process; track off-targeted production outputs, troubleshoot/perform root cause analysis, and make technical and compliance related recommendations as required.
    • Partner with support functions to effectively plan and lead implementation of manufacturing continuous improvement initiatives as it relates to sustaining products; examples include but are not limited to:


      • Scale up projects to meet anticipated business needs,
      • Identify and quality new/changes to materials meeting product, process, QS and regulatory requirements
      • Introduction of new automation equipment and/or changes to existing manufacturing processes.
      • Present clear and concise written and oral communications to colleagues and supervisors, lead and participate in technical meetings, and provide recommendations based on results.
      • Author technical documents, such as plans/protocols, engineering reports, SOPs, or other manufacturing related documentation.

        Requirements:

        • Work experience in production, pilot plant, and/or product development following GMP best work practices and techniques is required.
        • Work experience with NPI projects, design change control programs, and having an understanding of product lifecycle management
        • Experience with DOE techniques, statistical analysis, and statistical process controls.
        • Experience with various manufacturing process workflows, automation and equipment used to support production of multiple product lines.
        • Demonstrated ability to accomplish goals while working across departments is required.
        • Demonstrate capability to support the process and/or test methods development activities.
        • Demonstrate ability to problem solve, provide technical evidence for support and make decisions.
        • Ability to communicate effectively and build strong relationships across multiple departments.
        • Ability to work in fast-paced environment; easily adaptable to changing priorities.
        • Highly Desired:
        • Experience in editing or troubleshooting process workflows, production lines and automation equipment
        • Knowledge of various laboratory techniques, may include but not limited to, analytical methods (e.g. HPLC, LC-MS, and spectrophotometry), nucleic acid-based techniques (e.g. PCR, array hybridization, etc.) and biochemical (enzymatic) assays.
        • Knowledgeable of electronic change management and document management systems; knowledgeable of ERP/MRP systems.
        • Knowledgeable of ISO 13485, ISO 147901, 21 CFR 820 / 11, or other regulatory requirements and its application
        • Education:

          B.S./M.S./ PhD in Biochemical Engineering, Bioengineering, Biotechnical Engineering, Bioinformatics, Biological Sciences, Materials Science or Physical Chemistry or equivalent disciplines with: 2-4+ years of industry experience with a PhD, 5-7+ years of industry experience with a MS/BS


          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.Illumina believes that everyone has the ability to make an impact, and 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. 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

Keywords: Illumina, San Diego , Senior Process Development Engineer, Engineering , San Diego, California

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