Manager or Specialist, Vaccine DP Development / ワクチン製剤技術研究　担当者または課長代理

OBJECTIVES/PURPOSE Deliver optimal designs, operating procedures and maintenance programs for GMP and non-GMP Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Maintain accurate, consice, effective, up to date operating procedures and maintenance plans for Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Drive continuous improvements through defect elimination in System Design, Operations and Maintenance program and processes Support Sustainability initiatives related to Plant Utilities Systems (e.g. energy, water, waste reduction) ACCOUNTABILITIES Acting as a Plant Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for utilities (black and clean) and sustainability related activities. In detail, He/she will: Report to the Engineering Manager. Develop and maintain utility concepts and engineering scope based on the approved budget and schedule. Ensure that all utility systems meet regulatory requirements, client specifications, and industry standards and defines the user requirements. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with the external design company on the procurement strategy and procurement packages definition related to its discipline. Review and approve design documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. Manage the resolution of technical issues.

【職務内容】 光工場の新設工事ならびに改良工事における、洗浄バリデーション業務を実行します。 ・医薬品製造設備の洗浄プロセスを評価し、バリデートする責任を負います。 ・主な業務には、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、最終報告書の作成、最終バリデーションパッケージの作成、プロジェクト計画の作成が含まれます。 ・イニシャルバリデーションと再バリデーションの両方の責任を有します。さらに、製造上の課題の調査を行い、プロセスの改善を評価し、報告文書を作成します。 ・規制当局への文書提出、またはそれをサポートし、内部および外部の査察の際、必要に応じて利用できるように保管・管理します。 上記の業務を製造部門、エンジニアリング部門、薬事部門、品質管理部門、品質保証部門と日々連携して業務を行います。

【職務内容】 光工場における製品出品計画を達成するため、原材料・製品に関する微生物学的な試験の実施、試験引継ぎ、SOP・記録書の作成および安定性調査・バリデーションなどに関する試験を行う GMP要件に基づく試験（原材料・製品の微生物学的試験） 査察や監査時の対応 試験に関する技術・技能継承 公定書、申請書の試験に関連する業務 作業改善・効率化に関する業務 最新技術（迅速微生物技術等）の導入に関する業務 チームリード： 生産計画と出荷計画に基づいて試験計画を作成・実行 無菌試験 エンドトキシン試験 微生物限度試験 マイコプラズマ否定試験 培地充填試験 微生物同定試験 環境調査、工程使用水の微生物学的試験 試験業務に関連する専門知識を共有してチームメンバーの能力向上を推進

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