Senior Validation SME Manager for Cleaning Validation, Engineering at Hikari Plant

【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.

将来の大阪工場のサイトマスタープランに基づくPlant Engineering計画立案、設計、施工 カーボンニュートラルへの取り組み 第一種エネルギー管理指定工場としての省エネ法の対応業務 ユーティリティ設備の運転／監視の委託先の管理業務 工場におけるユーティリティ（電気、蒸気、市水、工業用水等）の供給管理、ユーティリティ設備の管理業務 グローバルネットワークの中の１工場として、上記業務を推進していくとともに、ハンズオンで改善・改革をリードしていくマインドやスキルが求められます。

OBJECTIVES/PURPOSE Ensure Process Equipment is “fit for purpose” for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements Main objectives (key services) Technology selection Review Capacity Modeling developed by Engineering company Engineering and Equipment Design Safety engineering design and management Recommend strategic preparation of project for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions ACCOUNTABILITIES Acting as Process Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for process equipment. In detail, He/she will: Report to the engineering manager. Develop and maintain process equipment concepts and engineering scope based on approved budget and schedule. Ensure that all process equipment meet regulatory requirements, client specifications, and industry standards and define the user requirements. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with external design company the procurement strategy packages definition related to its discipline. Review and approve design documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. Lead commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment. With Partners in Engineering Validation support the Qualification and Validation activities for Process Equipment. Perform Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Black Utilities Operations, Maintenance, Calibration, Reliability, Automation.

ACCOUNTABILITIES Serve as the Platform Operations Manager. Ensure service delivery teams use approved GDD&T tools and methods when delivering services to customers. Influence the existing complex landscape and solutions by innovating, redefining and simplifying process and technology designs, propose and execute solutions to identified highly complex IT pr Ensure service delivery teams use approved GDD&T tools and methods when delivering services to customers.oblems or process driven agile approaches. Drive the Platform Operations by creating, monitoring and adapting the processes and metrics for the products and platform. Owns the processes around Platform support, including monitoring and alerting, as well as escalation and post-mortem processes. Owns the 24x7 platform operations management and relationship with ICC/ICS and operations outsourced provider. Support the platform team to Introduce new capabilities, delivering business outcomes, in terms of speed to value and mean time to repair as well as client satisfaction. Ensure advanced capabilities are in steady operation, using scripted infrastructure and automation techniques. This will require collaborate with existing teams who currently manage our deployments to maintain a proper production system. Work independently on tough problems with other team members and independently solve, with some guidance, very difficult technology problems. Demonstrates advanced tooling and techniques to other technical organizations throughout the company. CORE ELEMENTS RELATED TO THIS ROLE Provision, manage and maintain the infrastructure that supports plaform and the customers. Identify and execute improvement actions for platform operations, including championing exploration and incubation of advanced technologies. Track, manage, and communicate platform operations performance. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Work independently on highly complex problems with other team members and independently solving, with some guidance, very difficult technology problems. Demonstrates advanced infrastructure tooling and techniques to others across the rest of IT. Demonstrated in depth knowledge of key patterns and industry awareness of trends in the bio/pharma industry with a specific focus on Patform operations. Leadership Ability to manage direct reports and influence ICC/ICS and 3rd party providers to deliver at appropriate levels of quality, response times, stability and agility. Ability to manage and influence the general platform community across to a modern ecosystem. Align and Drive agile and platform driven operations groups to a better end-state. Decision-making and Autonomy Ability to drive our third-party support teams to maintain a stable analytics ecosystem. It will require the need to make tactical decision when needed to our operational environments. Ability to work through/complex and propose proper technology choices. Independently manage day to day operational issues while knowing when to escalate more critical problems or decisions in the environment. Interaction Interact with and influence cross functional team members, including Platform teams, Functional Leads, Business Partners, Product Owners and others. Coordinate and oversee plafform architecture, engineering and delivery teams at a technical level and coordinate different technical aspects across the ecosystem. Align with Enterprise Architecture, Platform Team and Quality Teams to make sure services co-exist with other best practices and deployments. Complexity Ability to distill complex operational feedback into actionable strategies, implementations and stable deployments. Ability to have an agile time-based delivery team operate within a traditional project and waterfall-based funding and approval cycles. Drive complex deployments to implementation and deployment. Many of these solutions are difficult to make stable at scale.