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Process Engineer II - Process Monitoring

United States - California - El SegundoProcess/Product Development & OperationsRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

Kite is seeking a highly motivated individual with biotechnology experience to work on innovative T cell therapies for cancer treatment. As a Process Engineer II for Manufacturing Sciences and Technology (MSAT), you will provide process science support for commercial GMP manufacturing, technology transfers, development studies, validation, and continuous improvement projects for Kite’s engineered T cell therapy products. Additionally, you will author product impact assessments, root-cause analysis reports, sampling plans, technical reports, and provide analytical oversight for GMP manufacturing for Kite’s engineered autologous T cell therapy products which will require statistical and trending analysis and process monitoring.

Responsibilities (include but are not limited to):

  • Perform process support as process development representative for manufacturing site
    • Author impact assessments and root cause analysis for major and critical trend deviations and determine appropriate CAPAs
    • Support cross functional teams to perform root-cause investigations and deviation resolution for moderately complex problems
    • Lead data-based deviation resolution and improvement projects
    • Authoring of process monitoring reports
    • Monitor process performance through data-based trending
    • Data based deviation resolution and improvement projects
    • Collaborating with technical and operational stakeholders, write and review SOPs and other data collection related documents as needed
  • Perform data analytical studies to support ongoing projects.
  • Author protocols and reports for data analytics and continuous process verification.
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
  • Support process development for global change management and process related CAPAs
  • Support regulatory inspections and projects for regulatory commitments
  • Understanding of process development, validation, and Lifecycle management to support comparability studies, process validation, and licensure changes
  • Act as communication channel between global organizations and site manufacturing

Requirements:

  • BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 4+ years of relevant experience or
  • MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 2+ years of relevant experience or
  • HS Diploma with 6 + years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent

Preferred Qualifications:

  • Expert Knowledge of data management tools and statistical process controls
  • Experience in statistical analysis using JMP or Minitab
  • Working knowledge of scientific and engineering principles
  • Well-developed computer skills
  • Knowledge of pharmaceutical manufacturing of biotechnology products and process development
  • General knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
  • Experience working with or leading cross functional teams to obtain project deliverables
  • Working knowledge of scientific and engineering principles
  • Certified Quality Engineer, Six Sigma Green Belt  is a plus
  • Knowledge of ERP systems implementation is desirable

Does this sound like you? If so, please apply today!
 

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