Validation Engineer, Narita Plant / 成田工場 バリデーションエンジニア

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

esponsible for the following matters in Osaka Plant In collaboration with the plant management, lead the development and implementation of management systems and site procedures concerning environmental, health, safety using the ISO14001(Environment) and ISO45001(OHS) Lead EHS related compliance including waste water management Strive for sustainable global envirionment with zero-emission and carbon neutral Lead projects of Safe Initiative program, BCP, and security to formulate annual plan by closely monitoring the transition Ensure the requirements of corporate EHS and other related departments are in place Supervise / host EHS-related committees or meetings Lead EHS programs in association with Osaka plant restructuring with duties of government and neighboring affairs Elevate the capabilities of Osaka Plant organization for now and the future through the cross-functional collaboration Evaluate change proposals from the EHS aspects (for example, Safety, legal response and so on) on the change management process, as a EHS SME Ensure ethics and compliance DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise: Have theory-based systematic and practical knowledge on Environment Occupational Health and Safety for fulfillment of duties Comprehensive understanding of regionally emerging EHS legislation and experience of proactively responding to legislation changes Proven experience in auditing against EHS management systems Capability to train people in EHS&S methodologies Strong analytical skills and ability to convert informational data into action plans Strong customer service and responsiveness to others Sense of urgency and ability to achieve results Leadership: Make quick and practical decisions in case of emergency Provide leadership and direction to achieve the safety workplace vision through management commitment and employee ownership Take initiatives in EHS-related projects in Osaka Strong results orientation, leadership capabilities and overall structured way of working Decision-making and Autonomy: Set goals and processes in line with corporate EHS starategies and policies Facilitate senior level decision making in relation to people management practices Interaction: Create, develop and maintain relationships within GMSGQ Japan and with other divisions, affiliated companies, external experts and government office for prompt execution of EHS measures at Osaka Plant Strong interpersonal skills to get along with all levels of the organization Lead improvement of local, regional, and national EHS issues around the site Innovation: Develop and implement solutions by observing and referring to similar EHS issues within and outside the company Lead and engage team members for the AGILE program to drive continuous improvements and innovation Complexity: Ability to translate complex information into simple actions Extensive and pragmatic view beyond the site Coordinate EHS strategic matters with each department and affiliated companies in Osaka Plant

募集部門の紹介 医薬品製造工場の設備(建築、機器、空調、配管、電気、計装）に関するオーナーズ・エンジニアリング業務（自社の立場に立ったエンジニアリング業務）を実施している部門です。 職務内容 予備部品管理者/管理者の指示の下、予備部品及び保全資材の受領、保管、移動を含む、効率的かつ効果的な日常の物品管理活動 予備品倉庫/保管室の物理的セキュリティの日常的なモニタリング及びすべてのセキュリティ関連の問題の管理者への報告 Efficient and effective daily warehouse activities, including the receipt, storage, staging and movement of spare parts and maintenance materials under direction of Spare Parts Supervisor / Manager Day-to-day monitoring of physical security in the spare parts warehouse/storeroom and the reporting of all security-related issues to management

【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。