Specialist or Manager, Plant Maintenance Engineering, Osaka Site / 大阪工場 機械保全技術者 (一般社員又は課長代理)

OBJECTIVES/PURPOSE Coordinating the engineering activities of about 1000 Oku Yen investment at the Osaka Site, Japan, to implement an end to end manufacturing facility for Plasma Derived Therapy products including Drug Substance (DS), Drug Products (DP), Inspection and Packaging (I&P) and a Cold warehouse. ACCOUNTABILITIES Develop and manage project budgets, ensuring that all expenditures are in accordance with approved budgets. Manage project risks, ensuring that risks are identified, assessed, and mitigated in a timely manner Provide regular project status updates to senior management and other stakeholders. Ensure compliance with all applicable regulations, guidelines, and policies. Provide regular management up-dates and act as an enabler for individual project teams. Use project management methodologies and skills to manage the capital project across organizational boundaries and is responsible for its successful delivery. Ensures the project is conducted at the highest quality, within time and budget, and that the risk level and stakeholder expectations are managed. Ensures adherence to the GMS GOP - Planning and Execution of Capital Investment Projects Coordinates and supervises project execution related activities, from initiation to close out and successful hand-over. Leads a cross functional team of internal and external specialists. Responsible for meeting project scope requirements, schedule requirements, and costs. Interfaces with major projects/initiatives at the specific plant. Transfers best practices across functions and business units as well as other sites. Ensures compatibility and consistency with the existing organization and industry standards (PMM, cGMP, GEP, etc.) Coordinates with all stakeholders, facilitates problem solving sessions and or other planning sessions, and makes adjustments to the project in alignment with the overall business strategy. Responsible for the adequate utilization of all quality systems as defined by Procedures within the project organization. Ensures appropriate safety measures are taken to prevent injuries and minimizes safety risks. Ensures readiness for inspections together with quality organizations. Ensures compliance with rules and regulations of procurement and accounting.

OBJECTIVES/PURPOSE A Computer System Validation (CSV) engineer is responsible for ensuring that computerized/automation systems used in the manufacturing, testing, and distribution of pharmaceutical products are validated and comply with regulatory requirements. The CSV engineer works closely with cross-functional teams, including manufacturing/production, IT, quality assurance, and regulatory affairs, to develop and execute validation plans, protocols, and reports. ACCOUNTABILITIES Acting as Computer Systems Validation (CSV) engineer in the Engineering workstream of the project, he/she will: Report to the CQV Lead/Validation Manager. Develop and execute validation plans, protocols, and reports for computer systems. Ensure that computer systems are compliant with regulatory requirements, including FDA regulations, GxP guidelines, and industry standards. Collaborate with cross-functional teams to identify and mitigate risks associated with computer systems. Conduct risk assessments and develop risk mitigation strategies for computer systems. Develop and maintain standard operating procedures (SOPs) for computer system validation. Provide training and guidance to end-users on the proper use of computer systems. Participate in audits and inspections to ensure compliance with regulatory requirements. Keep up-to-date with industry trends and best practices related to computer system validation. Manage vendors/contractors related to CSV activities.

職務内容 １．グローバルチーム及びサイトチームと連携し、電子バリデーションシステム（Kneat）の日々の運用・保守と継続的な改善を推進する。また、マイナーなソフトウェア変更作業、変更管理の作成、レビュー、および承認を行う。 ２．サイトおよびグローバル・プロジェクトに、エンジニアリング・コンプライアンスと電子バリデーションシステムにおける広範な知識とリーダーシップを提供する。 このポジションは、エンジニアリング・コンプライアンスに関して下記を保証する。 ・関連法規制要件、業界標準及び社内基準に対するコンプライアンス ・バリデーション活動に対する査察準備と実行 ・バリデーション担当者のトレーニング ・エンジニアリングサービス関連の活動に関連するRCA（Root Cause Analysis）/CAPA（Corrective Action & Preventive Action）のサポート ・バリデーションドキュメント管理のサポート ・品質/バリデーションカウンシルで提示される指標管理（バリデーションメンテナンスなど） 仕事のやりがい ・GMP環境下で実施するバリデーション文書作成、承認及び保管、並びにデータを記録するための標準ソフトウェアである電子バリデーションシステム（Kneat）のスキル、また深い知識及び経験を獲得できる。 ・獲得した電子バリデーションシステム（Kneat）の知識、経験を活かして、バリデーション活動で活躍することができる。 ・バリデーションに関連したコンプライアンス活動をリードすることで、成田工場及びGMP及びコンプライアンスの向上に貢献できる。

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.