Site Lead Power User for E-Validation System / Engineering Compliance

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。

●日本における臨床試験に関する安全性業務 ・臨床試験における安全対策立案と関連文書の作成・レビュー ・グローバル開発チームのPV担当との折衝・情報共有 ・治験薬に関する安全性評価（個別症例評価ではない） ・治験薬の安全性に関わる文書の作成（治験年次報告書等） ・承認申請における安全対策立案（添付文書「使用上の注意」、RMP等）、審査対応 ●日本における承認後の安全対策に関する業務 ・市販直後調査 ・安全性情報のシグナル／リスク評価・安全対策立案（添付文書「使用上の注意」、RMP等） ・安全性定期報告等の定期報告書の作成 ・再審査申請における安全性評価 ●グローバル安全性評価チームにおける安全性評価、安全対策立案等

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

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.