＜製造本部＞製造技術/担当・担当課長・課長/P1-P3/西神工場/

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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. Create and maintain technical documents and SOPs, including specifications, procedures, and validation plans/reports. When quality or technical issues are detected, work with relevant departments to identify root causes and develop CAPA. Understand internal and external standards and work with relevant departments to appropriately incorporate them into the site and processes. Collaborate with global sites to appropriately integrate technical requirements and best practices into the site and processes. Provide technical solutions to support process team or site activities and decision-making in a timely manner. Lead projects aimed at driving operational excellence. Work with relevant departments to provide technical support to contract manufacturers. Develop a deep understanding of Lilly corporate standards and regulatory requirements from the perspective of process control strategy, and drive improvements when gaps are identified. Understand and adhere to employee requirements, such as Lilly Values, the Red Book, and ethics and compliance standards. Build strong working relationships with colleagues across departments to implement technical and business solutions. Make balanced and flexible decisions considering quality, productivity, and business needs. Pay constant attention to safety and health activities and proactively contribute to building a strong safety culture to achieve zero workplace accidents. Required Experience (mandatory for hiring) Education: 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. Attributes: Ownership and leadership. Language: Japanese (native level) and English (business level, equivalent to a TOEIC score of 700 or above) Additional Preferences: Experience with data analysis using digital tools, including statistical analysis Experience in team management and people development ＜職務内容/Job Responsibilities＞ 関連部門と連携し、顧客の期待や規制要件を満足するような検査・一次包装・二次包装プロセスを設計する。また、それを検証し、モニタリングする。 仕様書、手順書、バリデーション計画書/報告書など、技術文書とSOPを作成し、維持管理する。 品質・技術的問題が検出された場合は、関連部門と連携し、根本原因を特定し、CAPAを立案する。 内外のスタンダードを理解し、関連部門と連携し、サイトやプロセスに適正に取り入れる。 グローバルサイトと連携し、技術的な要求事項やプラクティスをサイトやプロセスに適正に取り入れる。 プロセスチーム/サイトの活動または決定をタイムリーにサポートするための技術的な解決策を提供する。 卓越性の追求のためのプロジェクトを主導する。