Specialist, KAIZEN promotor/ スペシャリスト、改善活動推進担当者

Responsibilities 1. Collaborate closely with pharma science, regulatory, and quality control organizations, as well as process experts across our global plasma network. 2. Provide leadership and guidance to team members, assisting them in prioritization, problem resolution, and process clarification. 3. Direct the effective transfer of technology from design development to implementation. 4. Evaluate the suitability of new technologies for implementation and transition to the manufacturing floor. 5. Ensure successful product technical transfer to the new plasma facility. 6. Establish reliable yield status and accurate yield forecasts for all transferred products, implementing strategies to meet yield targets. 7. Develop and direct strategies for yield improvement projects, lead time reduction, process security, and deviation reduction. 8. Assure process robustness and supply reliability by controlling the manufacturing process life cycle. 9. Develop strategic plans that incorporate regional and global business practices and customer needs. 10. Define and communicate strategic imperatives for project success, including market entry timing, innovative technology, and costs. 11. Develop effective tech transfer project milestones, schedules, and manage budgets. 12. Utilize state-of-the-art project management tools to ensure project schedules and budgets are met. 13. Identify and resolve issues that may impact project schedules or improve project time. 14. Understand and effectively communicate market niche and competitive forces influencing the project. 15. Ensure team objectives align with key tech transfer projects for the new facility. 16. Proactively prioritize and balance resource utilization for the project. 17. Select, develop, and retain staff, providing constructive feedback, recognition, coaching, mentoring, and motivation. 18. Generate innovative solutions to complex problems using multiple disciplines and technical principles. 19. Create innovative products, processes, and methods through novel combinations of expertise within the organization. 20. Perform other duties as assigned. Qualifications 1. Utilize your strong scientific background to contribute to the development and optimization of plasma manufacturing processes. 2. Apply your knowledge of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods to ensure compliance and continuous improvement. 3. Demonstrate self-motivation, strong interpersonal skills, and the ability to analyze and solve complex problems through innovative thought and experience. 4. Utilize project management tools to effectively manage multiple cross-functional teams simultaneously. 5. Design and implement projects/studies outside your area of expertise, leveraging your scientific knowledge and skills. 6. Provide strategic leadership and supervision to ensure the success of process development and tech transfer projects. 7. Utilize your experience in change management to drive process improvement initiatives. 8. Demonstrate a high level of customer orientation and organizational skills. 9. Embrace a flexible and innovative mindset, thinking outside the box to drive continuous improvement. 10. Communicate effectively, both verbally and in writing, to convey complex scientific concepts and project updates. 11. Leverage your record of success in process development, tech transfer, project management, and regulatory submissions to drive the success of our plasma manufacturing processes. 12. Collaborate with cross-functional teams in a highly matrixed, cross-functional, and geographically dispersed environment. 13. Utilize your experience in GMP inspections to ensure compliance with regulatory requirements.

【職務内容】 ステークホルダから要件をヒアリングの上でエンジニアリング会社などと原薬・バイオ製造設備、製剤・包装設備のF/S, FEEDを行いプロジェクトリードとして設備計画を取りまとめる。小規模なプロジェクトでは自身が基本設計を行う場合がある。 設備計画が承認された際には引き続き競争入札の上でEPCを実施してコミッショニング、クオリフィケーションを行いPQ以降の工程を技術/現場/保全部門へ引き継ぐ。 生産設備や用役設備の中長期的な計画を策定・管理を行うことでサイト戦略を立案する 品質保証に関する業務を理解して必要なドキュメントの作成、レビューを行うとともに各域当局、グローバルエンジニアリング組織からのガイダンスを確認して既設設備の評価を行う。 Responsibilities: The department supports the lifecycle (installation, startup, operation, and renewal) of all Hikari facilities. After hearing requirements from stakeholders, conduct feasibility studies and concept designs for formulation/packaging, bio/pharmaceutical production facilities and service facilities, and compile facility plans. The site strategy is developed by formulating and managing mid- to long-term plans for production facilities and service facilities. Planning, drafting, designing, giving production instructions to suppliers, commissioning, and qualification of production facilities for solid and sterile drugs, packaging, or biotechnology and active pharmaceutical ingredients, and guiding the facilities. The candidate will be responsible for the planning, drafting, designing, giving manufacturing instructions to suppliers, commissioning, qualifying, and guiding the equipment.

【職務内容】 光工場の新設工事ならびに改良工事における、洗浄バリデーション業務を実行します。 ・医薬品製造設備の洗浄プロセスを評価し、バリデートする責任を負います。 ・主な業務には、プロトコール作成、バリデーション作業の調整、バリデーションの実施、最終報告書の作成、最終バリデーションパッケージの作成、プロジェクト計画の作成が含まれます。 ・イニシャルバリデーションと再バリデーションの両方の責任を有します。さらに、製造上の課題の調査を行い、プロセスの改善を評価し、報告文書を作成します。 ・規制当局への文書提出、またはそれをサポートし、内部および外部の査察の際、必要に応じて利用できるように保管・管理します。 上記の業務を製造部門、エンジニアリング部門、薬事部門、品質管理部門、品質保証部門と日々連携して業務を行います。

募集部門の紹介 医薬品製造工場の設備(建築、機器、空調、配管、電気、計装）に関するオーナーズ・エンジニアリング業務（自社の立場に立ったエンジニアリング業務）を実施している部門です。 職務内容 予備部品管理者/管理者の指示の下、予備部品及び保全資材の受領、保管、移動を含む、効率的かつ効果的な日常の物品管理活動 予備品倉庫/保管室の物理的セキュリティの日常的なモニタリング及びすべてのセキュリティ関連の問題の管理者への報告 Efficient and effective daily warehouse activities, including the receipt, storage, staging and movement of spare parts and maintenance materials under direction of Spare Parts Supervisor / Manager Day-to-day monitoring of physical security in the spare parts warehouse/storeroom and the reporting of all security-related issues to management