＜製造情報技術部＞Manufacturing IT, Production Function Business Integrator・MES Engineer / Associate・Manager・Senior Manager /Seishin Manufacturing Site）

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly’s Purpose Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing around the world to build new state-of-the-art manufacturing site’s and continue growing our existing facilities to created capacity required to continue with our mission. Seishin site started journey to apply the newest technology, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. What You’ll Be Mainly Doing: We are on a daring journey to transform our manufacturing operations, and the Manufacturing Execution System (MES) is pivotal to achieving this transformation. Multiple projects are currently underway to expand the footprint of MES, enabling Seishin site to operate paperless and modernizing MES in established operations worldwide. This position will ensure the successful implementation of the MES solutions and other production systems by bridging business needs and technology. This role will develop expertise in PharmaSuite , supporting, developing and validating global electronic batch records to fulfil business needs. Working closely with global and site teams, they will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges. Key Responsibilities: Develop and integrate MES common and site-specific components. Develops and/or assists in the creation and maintenance of the MES interfaces with other Lilly systems. Support MES solutions start up activities. Evaluate and translate functional requirements into technical solutions not limited to MES. Work with site resources towards replication & standardization to drive value and implement the appropriate technical solutions. Ensure project and/or validation documentation is maintained during lifecycle & release management. Evaluate new technologies and implications to existing Lilly footprint. Benchmark on innovative solutions (external and internal to Lilly) Maintain open communication with MES vendor(s) to address needs in standard solution or via functional packs. Dynamically adapt roadmap to site evolution/strategic directions, and new trends/issues. Establish a strong site culture based in Lilly values, expectations, and operational excellence standards. What You Should Bring (preferred skills ): Effective people and team leadership skills Ability to manage and contribute to multiple concurrent activities and adapt to changes in priorities. Ability to cross functionally collaborate. Business level written and oral English communication skills. Demonstrate creativity, analytical thinking, and the ability to troubleshoot and tackle problems. History of promoting safety and maintaining a safe work environment Demonstrated adhere adherence to compliance for internal and external quality guidance. Demonstrated and promote Operational Excellence Effectively encourage knowledge sharing and education Ability to problem solving and work through manufacturing situations. Have experience serving as an escalation contact with vendor(s) Basic Requirements: Bachelor’s degree in engineering, Computer Science, Information Technology, or a related technical field or Minimum 2 years of experience working with Manufacturing Execution Systems (MES). Experience with any MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. From the perspective of employee well-being and productivity, Lilly has established a commuting distance and time limit policy. Specifically, the maximum allowable commuting distance is within 90 km and commuting time should not exceed 90 min from candidates nearest station to the workplace using the cheapest public transportation. If candidates live further away than the above range, they will generally be required to relocate to a location within commuting distance (rented company housing may be provided). The above applies even if commuting by car is permitted. Excellent written and oral Japanese communication skills. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials. Ability to work cross-functionally and communicate effectively with technical and non-technical stakeholders. Additional Information: Position locations: Seishin, Kobe, Japan Occasional off-hours and weekend work expected. In principle, work at the site Some international travel may require. Business Title : Manufacturing IT, Production Function Business Integrator ・ MES Engineer ​ Lilly ’ s Purpose Lillyは現在、成長の著しい時期を迎えており、世界中の患者に革新的な医薬品を届けることに尽力しています。Lillyは世界各地で最先端の製造拠点を新設し、既存施設の拡張にも投資を行い、ミッションの継続に必要な生産能力を確保しています。西神工場では、最新技術、高度に統合された自動化製造システムの導入を進めており、環境への影響を最小限に抑えることにも注力しています。 主な役割 私たちは製造業務の変革という大胆な旅に乗り出しており、その実現にはManufacturing Execution System（MES）が不可欠です。現在、複数のプロジェクトが進行中で、MESの導入範囲を拡大し、西神工場のペーパーレス化を推進するとともに、世界中の既存業務のMES近代化を進めています。 このポジションはビジネスニーズと技術の橋渡しを行い、MESソリューションや製造におけるITシステム導入を成功に導きます。その中でPharmaSuiteの専門知識を習得し、ビジネスニーズに応えるグローバルな電子バッチレコードのサポート、開発、バリデーションを行います。グローバルおよびサイトチームと密接に連携し、バリデーション要件への準拠を確保し、技術的・運用的・ビジネス的な課題に積極的に対応します。 主な業務内容 • MESの共通およびサイト固有のコンポーネントの開発・統合 • 他のLillyシステムとのMESインターフェースの作成・保守の支援 • ITソリューションの立ち上げ活動の支援（MESに限らない） • ビジネス要件を技術的ソリューションに変換・評価 • サイトリソースと連携し、価値創出と適切な技術ソリューションの導入を推進 • プロジェクトおよびバリデーション文書のライフサイクル管理・リリース管理の維持 • 新技術の評価と既存Lilly環境への影響の検討 • 革新的なソリューションのベンチマーク（社内外） • MESベンダーとのオープンなコミュニケーションを維持し、標準ソリューションまたは機能パックによるニーズ対応 • サイトの進化・戦略的方向性、新たなトレンド・課題に応じてロードマップを柔軟に調整 • Lillyの価値観、期待、運用上の卓越性基準に基づいた強固なサイト文化の確立 求めるスキル（推奨） • 優れた人材・チームリーダーシップスキル • 複数の活動を同時に管理・貢献し、優先順位の変化に柔軟に対応できる能力 • 部門横断的な協働能力 • 優れた日本語による文書・口頭コミュニケーション能力 • ビジネスレベルの英語による文書・口頭コミュニケーション能力 • 創造性、分析的思考、問題解決能力の発揮 • 安全性の推進と安全な作業環境の維持の実績 • 内部・外部の品質ガイドラインへのコンプライアンス遵守の実績 • 運用上の卓越性の推進実績 • 知識共有と教育の促進 • 製造現場での問題解決能力。ベンダーとのエスカレーション対応経験があること 基本要件 • 工学、コンピューターサイエンス、情報技術、または関連技術分野の学士号、またはMESに関する2年以上の実務経験 • PMX、PharmaSuite（Rockwell）、Syncade-DeltaV MES（Emerson）、Werum PAS-XなどのMESプラットフォーム経験があると望ましい ・弊社では社員のウェルビーイングと生産性の観点から、自宅最寄り駅から勤務地までの通勤距離が90㎞以内かつ公共交通機関の所要時間*が90分以内の範囲を、通勤可能上限としています 。それよりも遠方にお住まいの場合は、通勤可能な範囲にご転居い