コンピュータ化システムバリデーション担当　シニアバリデーションエンジニア、エンジニアリング部 課長代理又は一般社員

職務内容 医薬品製造の各プロセス(原薬、製剤、検査包装)のいずれかの技術担当者として、以下の業務を担当いただきます。 原薬プロセス：原料血漿から分画(遠心分離やろ過など)を行って薬効成分を抽出し精製するプロセス。 製剤プロセス：薬効成分を安定化するため製剤処方化し、無菌的に充填するプロセス。 検査包装プロセス：充填したバルク医薬品を検査し、ラベルを貼付して、包装するプロセス。 ・製造サポート業務(生産トラブル対応、逸脱、是正/予防措置の対応) ・改善業務(製造法改良、現場改善活動のリード、デジタル技術導入、原価低減策立案、合理化技術検討) ・査察対応業務(申請書作成、査察時の対応) ・技術移管業務(グローバル製品の国内導入の対応、新設備/プロセスのクオリフィケーションなど) ・新棟建設業務のプロセス設計支援 ・製造に関する中長期計画/プロジェクト、技術継承の計画立案／仕組みづくり ・各種トレーニング計画／教育の実施

OBJECTIVES/PURPOSE Responsible for designing, developing, and maintaining electrical and automation systems. The successful candidate will work closely with cross-functional teams to ensure that all electrical and automation systems are in compliance with regulatory requirements and industry standards. Project engineering for the Strategic Automation Pillars in the areas of: Automation Security & Integrity Engineering Automation & Control Systems Data Integrity Automation Cybersecurity Automation Solutions & Systems Engineering Functional setups & architectures of systems & components Supervisory Control Structures & Data Mgt. Automation Data Engineering Standard Automation Integration Layer (Shopfloor Systems & Data Integration) Data Channels, HMI, displays & Visuals Historization Automation Data Governance Engineering Data Structures & Contextualization Use Case Owner Liaison Mgt, Technical2Business (and vice versa) translation ACCOUNTABILITIES 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 define 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.

職務内容 エンジニアリング部エンジニアリングサービスグループのコンプライアンス担当として、QMS（Quality Management System）の確立、グローバルSOPや業界標準の適用、変更管理、CQV（Commissioning & Qualification, Validation [Cleaning Validation/Sterilization Validation/Computerized System Validation]）担当者のトレーニング等の業務に従事いただきます。 また、グローバルチームと連携し、e-Validation（Kneat）システムの日々の運用保守と継続的な改善を行います。軽微なソフトウェア変更作業の作成、レビュー、および承認も行います。 以下の主な業務に従事いただきます。 グローバルSOPおよび業界標準(GMP、FDAガイドライン)の最新のCQV要求事項、ならびに医薬品製造プロセスに関する法的規制要求事項を工場へ提供し共有する。 ローカルSOP/フォームを更新/作成し、CQVの新しい要件とプロセスを実装するためのシステムの確立。 新しい要件に対する計画、スケジューリング、およびトレーニングの提供。 品質、製造、製造工学等の関連部門との間で、新たな要求事項や今後の取り組みについて説明し、同意を得る。 CQVに関する書類管理 グローバルチームおよび工場の担当ユーザーと連携して、Kneat システムの維持管理。 Kneat システムの変更と更新を実施し、工場の担当ユーザーと共有する。

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