Utility Engineer, Japan New Plasma Facility Project

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.

職務内容 グローバル製品の中長期需要・供給・在庫バランスのモニタリングと適正化の推進 S&OP（製品軸）プロセスにおける会議のファシリテーション、及びシニアマネジメントへの報告 供給課題発生時の課題解決、及びリスクマネジメントのリード 複数生産サイトを跨ったグローバル生産体制における、ネットワークキャパシティーアロケーションの提案 SAP/IBP、SAP/ERPシステムを使ったDemand Planning/Supply Planning/S&OPプロセスの自動化及び、可視化促進 サプライチェーンの最適化に関するグローバルプロジェクトへの参画、又はリード

- 工場基幹ユーティリティ設備の基本計画、技術検討、将来計画を立案すると共に、工事実施に際して設計、取引先への製作指示、コミッショニングを行うことで設備導入を図る。 - 上記の生産設備を設置する建物ならびに建物設備の企画、立案、設計、取引先への製作指示、コミッショニング、クオリフィケーションを行い、建設プロジェクトを実施する。 - ステークホルダから要件をヒアリングの上で生産設備、用役設備のフィージビリティスタディ、コンセプトデザインの検討を行い、設備計画を取りまとめる。 - 生産設備や用役設備の中長期的な計画を策定・管理を行うことでサイト戦略を立案する。 - 品質保証に関する業務を理解して必要なドキュメントの作成、レビューを行う。

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。