Senior Validation SME Manager for Cleaning Validation, Engineering at Hikari Plant

職務内容 工場の改善活動（AGILEプログラム）の推進リーダーとして以下の業務を遂行する。 １．工場の改善活動での工場の優先課題解決をリードする: 工場戦略実現のための優先事項に対する活動を現場メンバーと共に推進し、積極的に展開する 改善を推進する手法と様々なデジタルツールを習得する ２．多岐に渡る関係部門とのコラボレーションを図る： グローバルを含めた他工場、日本国内の多業種他社から改善のベストプラクティス事例を吸収し、工場内に共有し展開する 工場内やグローバル各工場に在籍する他の改善推進者と協力し合いながら、改善を推進する 改善成果発表会（国内外あり）での機会を活用して、多くの人たちとの信頼関係を築く ３．必要なコーチングの実践： 改善活動では「マインドセットとカルチャーの変革」を一つの重要なコンセプトとしており、工場リーダーシップを含む全従業員に対して常に「マインドセットと行動」の変革を促す 工場で開催されるトレーニングやワークショップへの参加を通じて、自分自身がファシリテーターとなったり、コーチングを実践する

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 以下のワクチン注射製剤の製剤開発に関する業務に従事頂きます。 製剤設計（処方、剤形の設計） 製剤製造プロセス設計（治験段階～商用に応じた製剤製造法の開発） バリデーション、治験薬製造設備・機器の管理、治験薬製造・供給 商用スケールへのスケールアップ検討、商用部門への引き継ぎ 申請書類の作成、照会事項対応、査察対応など

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