Associate Director, Global Master Planner, Supply Chain Management / サプライチェーンマネジメント部 グローバルマスタープランナー

職務内容 工場の改善活動（AGILEプログラム）の推進リーダーとして以下の業務を遂行する。 １．工場の改善活動での工場の優先課題解決をリードする: 工場戦略実現のための優先事項に対する活動を現場メンバーと共に推進し、積極的に展開する 改善を推進する手法と様々なデジタルツールを習得する ２．多岐に渡る関係部門とのコラボレーションを図る： グローバルを含めた他工場、日本国内の多業種他社から改善のベストプラクティス事例を吸収し、工場内に共有し展開する 工場内やグローバル各工場に在籍する他の改善推進者と協力し合いながら、改善を推進する 改善成果発表会（国内外あり）での機会を活用して、多くの人たちとの信頼関係を築く ３．必要なコーチングの実践： 改善活動では「マインドセットとカルチャーの変革」を一つの重要なコンセプトとしており、工場リーダーシップを含む全従業員に対して常に「マインドセットと行動」の変革を促す 工場で開催されるトレーニングやワークショップへの参加を通じて、自分自身がファシリテーターとなったり、コーチングを実践する

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.

【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

OBJECTIVES/PURPOSE Own 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 Capacity Modeling and Site Master Planning Engineering and Equipment Design Safety engineering design and management “Factory Floor” Continuous Improvement/ Troubleshooting / System ownership Own strategic preparation of sites for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions Provides leadership to all engineering disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget# The incumbent is responsible for improving existing equipment to minimize production downtime and provide leadership to all process equipment related investigations Develop and implement strategies to ensure cost and time effective designs while ensuring innovation and adhering to user requirements while managing daily operational support ACCOUNTABILITIES Technology selection Drive Cross functional stakeholder management with our Partners in Manufacturing e.g. Sciences and/or Pharmaceutical Sciences. Sponsor the evaluation and selection of new, state-of-the-art technologies and process equipment and applicable process equipment vendors (e.g. Robotics Single Use Technology) Identify future industry trends and decide on strategies for process equipment/technologies Own business case development for CAPEX investments in process equipment incl. Total Cost of Ownership (TCO) calculations Manage Process Equipment Vendors and Architectural/Engineering firms in the delivery of CAPEX and OPEX projects in areas of responsibility Capacity Modeling and Site Master Planning Mentoring of Process Unit Operation Capacity models and identify capacity bottlenecks / constraints in GMP manufacturing processes / production process and in the utilities delivery systems Apply knowledge of heat transfer, mass transfer, fluid dynamics, reaction kinetics to solve common process engineering problems Engineering and Equipment Design Own Front-End Engineering and Design activities in feasibility study and conceptual design phases Sponsor Project Turnover Packages for Process Equipment are delivered to site and that critical engineering knowledge such as as-built drawings, operating and maintenance manuals, equipment and instrument data sheets, spare parts lists are maintained, remain accurate and up to date Gather requirements from Stakeholders - such as from Quality, Manufacturing, Reliability, Maintainability, Automation, and EHS – to decide on Process Basis of Designs, specifications and designs for Process Equipment, Process Control Systems, Process Instrumentation and Process Safety Systems and Devices Lead Scope of Work and RFx Packages for Process Equipment Vendors, Process Engineering Consultants, Architectural / Engineering services, Commissioning services and (Sub-) Contractors Sponsor commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment With Partners in Engineering Validation mentor the Qualification and Validation activities for Process Equipment SME Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Utilities Operations, Maintenance, Calibration, Reliability, Automation Safety engineering design and management Conduct Process Hazard Analysis (e.g. PHA-Hazop) of hazardous manufacturing / production processes and incorporate improvements into the design of process equipment, process control, and process safety systems Perform Design Reviews of all process equipment with relation to EHS and lead for the relevant changes Own Investigations for process equipment and implement Corrective and Preventive Actions (CAPA) “Factory Floor” Continuous Improvement/ Troubleshooting / System ownership Provide leadership the Manufacturing and Maintenance departments with troubleshooting activities of Process Equipment on the factory floor Owner continuous improvement activities for Process Equipment applying continuous improvement tools such as DMAIC, FMEA, RCA, identify improvements, design and implement improvements and sponsor 3rd level troubleshooting in collaboration with “Manufacturing” &” Manufacturing sciences” Mentor Management of Change for Process Equipment in area of responsibility Responsible for internal and regulatory Audits and Inspections Engage in the Process Engineering Community of Practice (CoP) through sharing of best practices and lessons learned DIMENSIONS AND ASPECTS Technical Expertise: Lead and mentor system/equipment specifications Determine basic causes, and develop and then follow up on recommendations for corrective actions Enable capabilities to perform troubleshooting on system/equipment Lead customer service problems and recommend design improvements Leadership: Displays and drives culture of -ism, PTRB, safety, and quality into the organization Be on the floor to study and train and recommend techniques to enable the team to improve existing equipment to minimize production downtime. Good interpersonal skills and be able to work effectively and efficiently in a team environment as leader, mentor, trusted advisor. Demonstrates strong communication skills to effectively communicate with all levels of professionals, both internal (local & global) and external Coach, motivate, develop, recognize and mentor the engineering staff, including senior level engineers and managers. Being a mentor developing future leaders Decision-making and Autonomy: Decision making on organizational changes to build the required capacity/capabilities Autonomy in decision making to the level of required alignment Decision making of short/mid & long-term impacts Interaction: CAPEX Project Teams, Manufacturing Sciences, Quality, Manufacturing / Production, Utilities/Facilities Operations, Plant/Facilities/Utilities Engineering, Reliability Engineering, Maintenance, Calibration, Automation, EHS, Procurement / Purchasing, Equipment Vendors, Architectural / Engineering Services Companies, (Sub-) Contractors, Consultants Innovation: Generate innovative solutions to highly complex problems Demonstrated problem solving skills to support resolution of Engineering, Manufacturing and/or Quality-related issues Complexity: Assess, analyze, advise, propose and direct improvements that will deliver greater productivity, capacity, reliability and compliance for the Process Engineering Department Ensure compliance to all regulatory GMP, Safety and Environmental requirements Shall interface with regulatory agency representative (e.g. FDA/EMA) as the site Process Engineering SME during internal and external audits and shall be able to defend current practices to such agencies Strong skills to work in matrix organization with excellent interpersonal, communication, influencing, and negotiation skills required