Sr Validation Subject Matter Expert- Computer Systems Validation, Japan New Plasma Facility Project

【職務内容】 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。

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.

OBJECTIVES/PURPOSE Leads team that ensures uninterrupted delivery of Safe, Sustainable, Resilient, Reliable, Compliant Plant Utilities (GMP and non-GMP) and Infrastructure to the manufacturing plant Support Global Sustainability Program objectives through the development of long range carbon/energy/water/waste reduction plans and deliver project portfolio of engineering solutions to meet the Site’s Environmental Sustainability goals and objectives ACCOUNTABILITIES Responsible for all black utility functions in the Plant: Utilities operations, Utilities Maintenance, Sustainability Engineering and Plant Engineering Accountable owner of site carbon project portfolio and long-range plan (MRP) in partnership with the Site EHS Sustainability Lead Monitor and report the Site’s carbon, energy, and water consumptions, identify trends and measure the effectiveness of sustainability engineering projects Leads, develops, and trains high performing utilities & facilities function and staff Member of the site engineering leadership team Owner for site utilities and facilities operations and maintenance budget and long-term asset management plan Primary site point-of-contact for internal and external carbon assessments Delivers site carbon operating mechanisms, goals/KPIs, and communication plan DIMENSIONS AND ASPECTS Interaction EHS Sustainability Lead, Utilities/Facilities Operations, Plant Engineering, Automation, Contractors, Consultants, CAPS Community of Practice

ACCOUNTABILITIES: Working closely with the Head of GIRM and other team members, participate in further developing a high-quality global insurance & risk management function considering all insurance and operational risk management needs of a global company. Participate in and lead insurance projects and assigned insurance programs (such as Directors and Officers Insurance) Support independently local Japanese subsidiaries in insurance related queries according to Global Insurance Guidelines Develop and maintain sound insurance reporting procedures and systems for collection and maintenance of underwriting information needed for e.g. renewal of local/ global insurances Responsible for assigned global insurance programs dealing with complex negotiations with (international) insurance companies and brokers on terms and conditions Take part in defining the scope of work for the insurance brokers who will assist us in order to acquire the most optimal insurance solutions for global insurance programs Maintaining relationships with insurance brokers (particularly those situated in Japan), industry consultants to develop, implement, maintain and update insurance risk management policies, procedures and programs to meet the company's changing environment. Support the global business on contractual risk management reviews and determine appropriate types and level of insurance. Responsible for the identification and assessment of risks to property, personnel, and ongoing business activities in general. Responsible for collection and review of critical underwriting data and preparation of insurance submissions for the assigned global insurance lines and participate in renewal negotiations. Prepare documentation on the assigned insurance lines for decision making on renewal activities by Senior Management Responsible for reviewing the assigned insurance policies for accuracy, recommending appropriate loss retention levels (deductibles, self-insurance levels, etc.) and negotiating insurance coverages, provisions, and premiums in the insurance markets. Support and work closely with other departments in the development and implementation of risk management actions relevant for the insurance lines mentioned Oversee the proper handling and settlement of claims for the assigned insurance lines Support GIRM colleagues with their assigned insurance lines per request Maintain Japan LOC network relationship. Participate in Risk Engineering especially for local sites. Responsible for local CAPEX stand-alone project insurances Maintain the relationship with Japan’s partner insurance agent