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

OBJECTIVES/PURPOSE This position will provide support to the execution of commissioning and qualification of a new Plasma manufacturing facility. This position is responsible to assess and qualify equipment, critical systems (utilities), facilities, computer systems, cleaning processes, manufacturing processes, as applicable. Primary tasks include development of protocols, coordination of commissioning and qualification activities, qualification execution, preparing final reports and assembly of final commissioning and qualification packages, and generation of project plans. Responsibilities will consist of both initial commissioning and qualification efforts as well as re-commissioning and re-qualification. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and will be included in or support regulatory submissions, and made available as needed during internal and external regulatory/compliance audits. This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis. ACCOUNTABILITIES Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculums, routine project procedures, project management, and other training as appropriate. Performs a variety of projects/studies in several areas at the same time to support project timelines and budgets while maintaining quality and compliance. Supports projects that require team participation. Must demonstrate competent and effective coordination, and organizational skills. Handles routine tasks with attention to detail, timely and accurately. Participates and interfaces with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification elements, as applicable, to determine commissioning and qualification strategy based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and qualification. Emphasis is on ensuring accuracy and integrity on commissioning and qualification documentation that meets regulatory guidelines and industry standards. Writes protocols and reports, executes, interprets, and evaluates commissioning and qualification documents in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, etc.). Utilizes Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC). Identifies gaps related to commissioning and qualification requirements and global procedures. May assist in closing compliance gaps as they are identified. Performs updates to element commissioning and qualification assessments and commissioning and qualification plans, as required. Participates, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions. Supports internal or external assessments or audits, as required. Supports process with timely closure of observations/audit items. Uses commissioning and qualification test equipment in support of commissioning and qualification activities. Performs other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have basic experience in pharmaceutical/biotech commissioning and qualification elements, as applicable, including the writing and executing of protocols and standard operating procedures. Must have basic knowledge of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus. Leadership Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems. Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization. Decision-making and Autonomy Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to design, execute and deliver to department goals and project goals. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity Must have advanced experience and proficiency in problem analysis and resolution, a successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

光工場の新設工事ならびに改良工事における、滅菌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 成田工場における新規設備大型更新、および新製品導入・既存製品増産に伴う設備導入・新棟建設等のプロジェクトの実行メンバーとなり、成田工場の未来を作り、ビジネスの堅強な成長を直接支える業務です。 医薬品製造設備の各導入プロジェクトの担当者として以下の業務に従事いただきます。 - 設備仕様の検討 - 予算策定、管理、購入検討 - 工事設置、生産立ち上げ - 機器や製造プロセスに関するレビューや技術的サポート - スケジュール管理・リスク管理 - 社内外の関係者との調整・交渉 - FDA等の規制監査対応 ※新規設備のFeasibility調査からクオリフィケーションまで、また既存設備の向上等多岐に渡ります。

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