Manager/Specialist, Process Engineer, Narita Plant / 成田工場　プロセスエンジニア、課長代理/Specialist

職務内容 保全活動、予備部品、設備稼働時間、設備・業務管理、安全対策の適切な計画と調整により、潜在的な遅延、欠陥、障害を事前に排除することにより、保全作業員の生産性と作業品質を向上させる。 校正を含むすべての保全作業の効果的かつ効率的な計画及びスケジューリング 製造・生産業務チームと保全組織との連携・調整を行う。 Improve maintenance work force productivity and work quality by eliminating in advance potential delays, defects and obstacles through proper planning and coordination of maintenance activities, spare parts, machine time, craft and labor needs, safety measures. Effective and efficient planning and scheduling of all maintenance work, including Calibrations Liaise and coordinate between the manufacturing/production operations teams and maintenance organizations

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 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

【職務内容】 医薬品製造設備や工場建屋の新設工事ならびに改良工事における、コンピュータ化システムバリデーション業務を担当します。 担当工事のコンピュータ化システムバリデーション責任者として、コンピュータ化システムを検査し、適切な仕様を満たしているかを評価します。 以下の主な業務に従事いただきます。 ・プロトコール作成 ・バリデーション作業の調整 ・バリデーションの実施 ・バリデーション報告書の作成 上記業務を実行するにあたり、製造部門、エンジニアリング部門、品質管理部門が日々連携して業務を行います。