Technology Support Engineer, Osaka / 技術サポートエンジニア 大阪_ID:751

OVERVIEW Project Controls Engineer Are you ready to take on complex challenges while building your career? Are you interested in helping ensure that projects operate at the highest quality, within a Site Engineering team that manufactures life-saving treatments for patients? Join us as a Project Controls Engineer in Osaka Plant. Every day, Engineers at changing lives, impacting millions, and shaping the future of healthcare. On our Site Engineering team, you will be empowered to implement comprehensive project cost and schedule planning, control processes, and manage risk in support of successful project delivery. You will have the authority to make choices that contribute to our greater purpose of improving people's lives while protecting our planet. Supported by talented and respectful colleagues, you will be offered stimulating experiences that enhance ongoing career opportunities. ENGINEER YOUR FUTURE ● Develop and manage comprehensive Basis of Schedule and Cost Estimate and integrate construction planning efforts. ● Develop manageable cost and schedule packages for use by the project team. ● Ensure schedule has complete scope coverage, procurement milestones are considered, critical path defined, and potential scope growth identified. Utilize industry and internal benchmarks to validate the quality of the overall schedule. ● Analyze cost performance, maintain the monthly cash flow forecast, and ensure control of budget and spend using an approved project change request process, including allowances and contingency. ● Monitor resource plan and periodically perform Earned Value Analysis where applicable. ● Work with key stakeholders to identify cost and schedule risks and apply quantitative risk analysis methods (e.g., Monte Carlo Simulation) where applicable. ● Develop and deploy appropriate project change management processes and risk mitigation procedures. ● Develop and prepare monthly cost and schedule reports based on project definition and execution phase. ● Lead subcontractors invoice management. Track the budget, expenditures, and Estimate At Completion. ● Assist procurement during the bidding process and tendering period by assessing proposed cost against budget. ● Ensure purchase requests are based on initial budgeted scope (or approved scope changes), place and approve Purchase Requests in Ariba, and monitor the purchase process. ● Liaise with site finance departments to ensure accruals and further reconciliations are updated.

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.

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.

GMPに関する知見を基に、新規ワクチンの商業生産化、そして既存ワクチンの更なる製造安定化と価値向上に資する業務を行っていただきます。 ＜新規ワクチンの商業生産化＞ ・ワクチン製造プロセス・設備に関する技術検討やバリデーションの立案・実行 ＜既存ワクチンの更なる製造安定化と価値向上＞ ・製造プロセス改良、有効期間延長、マテリアル変更に関する技術検討やバリデーション ・価値向上のための製品改良業務など （例）・最新GMPに対して洗浄バリデーションプログラム（分析対象物質、洗浄方法、サンプリング箇所など）のアセスメントを行い、それを文書化する。分析対象物質を正しく評価できる手法を開発し、変更後の洗浄方法が妥当であることを示すデータを製造部門と連携して取得する。 ・原材料や製造法の変更にあたり、変更が品質に与える影響を評価するために必要な情報を精査し、実験検討やバリデーションを立案する。ラボスケールや商用スケールで製品を試製してデータを取得し、変更が品質に与える影響を評価し、その変更を関連部門と連携して推進する。 ・プロジェクトチームと連携し、グローバルスタンダードの生産設備や製造プロセスをデザインし、投資額やタイムラインを策定する。