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Eli Lilly Eli Lilly · Pharma · Seishin laboratories, Japan

This role at Eli Lilly focuses on designing, validating, and monitoring inspection, primary packaging, and secondary packaging processes within pharmaceutical manufacturing. It involves creating technical documents, identifying root causes for quality issues, developing CAPA, and ensuring compliance with internal and external standards and regulatory requirements. The role also includes leading projects for operational excellence, supporting contract manufacturers, and collaborating with global sites. While data analysis and team management are preferred, the core responsibilities are process engineering and quality assurance in a regulated healthcare environment.

What you'd actually do

  1. Collaborate with relevant departments to design inspection, primary packaging, and secondary packaging processes that meet customer expectations and regulatory requirements. Also validate and monitor these processes.
  2. Create and maintain technical documents and SOPs, including specifications, procedures, and validation plans/reports.
  3. When quality or technical issues are detected, work with relevant departments to identify root causes and develop CAPA.
  4. Understand internal and external standards and work with relevant departments to appropriately incorporate them into the site and processes.
  5. Lead projects aimed at driving operational excellence.

Skills

Required

  • Bachelor’s degree or higher in a science-related field (such as Pharmacy, Engineering, Chemistry, or Science)
  • At least 5 years of work experience in pharmaceutical manufacturing or in a related support function
  • Strong problem-solving ability based on scientific and logical thinking
  • Ownership and leadership
  • Japanese (native level)
  • English (business level, equivalent to a TOEIC score of 700 or above)

Nice to have

  • Experience with data analysis using digital tools, including statistical analysis
  • Experience in team management and people development

What the JD emphasized

  • regulatory requirements
  • validate
  • validation plans/reports
  • quality
  • technical issues
  • root causes
  • CAPA
  • standards
  • technical requirements
  • process control strategy
  • regulatory requirements