Senior Process & Utility Engineer, Japan New Plasma Facility Project

職務内容 以下のワクチン注射製剤の製剤開発に関する業務に従事頂きます。 製剤設計（処方、剤形の設計） 製剤製造プロセス設計（治験段階～商用に応じた製剤製造法の開発） バリデーション、治験薬製造設備・機器の管理、治験薬製造・供給 商用スケールへのスケールアップ検討、商用部門への引き継ぎ 申請書類の作成、照会事項対応、査察対応など

As a member of the Engineering workstream of the project, provides guidance and leadership to all automation-related activities* in accordance with the Global Automation Strategy. In detail, He/she will: Report to the engineering manager. Develop and maintain automation guidelines and standards based on project approved budget and schedule, and ensure compliance Ensure that all automation systems** meet regulatory requirements, client specifications, and industry standards and defines the user requirements. Ensure compliance with Automation Standard Requirement Specification, Automation Engineering Guideline, compliance, and cybersecurity in the project. 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 automation documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. * Automation Security & Integrity Engineering Automation Solutions & System Engineering Automation Data Engineering Automation Data Governance Engineering **

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.

【主な業務内容】 • 社内ソフトウェアアプリケーションのサポート • 以下の技術専門分野における小規模ソリューションプロジェクトの技術標準分析、実装、評価に参加および実行 — エンドユーザーサポート — ハードウェアのトラブルシューティングと故障対応 — オペレーティングシステム・ソフトウェアのサポート — ハードウェア・ソフトウェアツールとITILプロセスに沿った運用 【詳細な業務内容】 • 問題の調査、解決策の分析、小規模なプロジェクトの技術的な変更の実装など • 要件、整備、テスト、問題、アプリケーション統合などの分析 • ガイドラインやポリシーに沿った意思決定のサポート、またはチームメンバーに対してのサポートに関する意思決定の支援 • 技術的な分析・設計・変更・ソフトウェア設定・ハードウェアの解決支援を標準に沿って実行 • 通常業務内やプロジェクト内でのアプリケーションの開発サービスやテクニカルサポートの提供 • ビジネスソリューションの本番環境への展開サポート、エンドユーザー機器のライフサイクルプロセスとIT資産管理 • 社内ITインフラストラクチャとエンドユーザー機器の対面式サポートの実施 • 会議室や会議イベントのサポート • システム改善策の実装支援 • 品質マネジメントシステム(QMS)、ソフトウェア開発ライフサイクル(SDLC)、およびITプロジェクトライフサイクル(ITPLC)の標準、ポリシー、および手順に従ったサポートドキュメントの作成・維持 • マネージャ・リーダーからの指導と指示の下での業務遂行 • 主要なITおよびビジネスの目的/目標を理解し、自己知識を独自の作業分野で活用 【関連業務】 • 計画された取り組みに対する定期的な更新と、テクノロジー運用とプロジェクトに関するレポートの提供 • 管理業務のデータ精度を確保