Project Controls Engineer(Associate Director), Japan New Plasma Facility Project

職務内容 主力生産工場にて、低分子医薬品、高活性医薬品の製造に関する下記業務を担当いただき、早期上市、安定供給および生産性向上に貢献いただきます。 ・新製品の工業化に向けた化学合成プロセス検討 ・国内外の製造委託先への技術移管及び技術指導 ・工場における原薬製造のプロセス改良およびトラブル解決 ・国内外での薬事申請・照会対応、ならびに当局・販社の査察対応 ・原薬製造プロセスへの新規技術の適用

職務内容 医薬品（注射剤）包装業務 - 上記製造業務に付帯関連する業務（日々の業務報告・トラブル対応・準備・片付け・清掃・改善活動など） ※業務具体例※ 包装機器の操作およびマニュアルでの包装作業 包装機器及び包装室の5S（整理/整頓/清掃/清潔/躾)活動 製造にかかわるドキュメントの制改訂などのパソコン業務

【職務内容】 工場における製品出品計画を達成するため、原材料・製品に関する微生物学的な試験の実施、試験引継ぎ、SOP・記録書の作成および安定性調査・バリデーションなどに関する試験を行う GMP要件に基づく試験（原材料・製品の微生物学的試験） 査察や監査時の対応 試験に関する技術・技能継承 公定書、申請書の試験に関連する業務 作業改善・効率化に関する業務 最新技術（迅速微生物技術等）の導入に関する業務 チームリード： 生産計画と出荷計画に基づいて試験計画を作成・実行 無菌試験 エンドトキシン試験 微生物限度試験 マイコプラズマ否定試験 培地充填試験 微生物同定試験 環境調査、工程使用水の微生物学的試験 試験業務に関連する専門知識を共有してチームメンバーの能力向上を推進

ACCOUNTABILITIES Manage, identify, hire, and develop a team to support commissioning and qualification of a new Plasma Manufac-turing facility. Manage continued growth, development, and retention of the team. Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate. Responsible for planning, scheduling, and leading commissioning and qualification assignments. Must demon-strate competent and effective planning, coordination, and organizational skills. Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification ele-ments, as applicable, to develop the commissioning and qualification strategy based on concepts of risk-based CQ which includes user requirements, functional specifications, design specifications, commissioning and qualifica-tion. Emphasis is on ensuring commissioning and qualification activities meet defined timelines and budget while being in compliance with regulatory guidelines and industry standards. Guide peers in Commissioning and Qualification and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results. Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate. Ability to present a course of action to management and project team using both written and verbal communication tools. Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present commissioning and qualification strategy and protocols in regulatory inspections. Supervise commissioning and qualification personnel, contractors and outside vendors to meet project timelines, goals and milestones. Monitor and report commissioning and qualification costs including capital and cross-functional expenses. Perform other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have vast experience, proficiency and leadership in pharmaceutical/biotech commissioning and qualification of large capital projects. which includes the writing and executing of protocols and standard operating proce-dures. Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all commissioning and qualification elements. 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, problem solving and team management. Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to meet timelines, budgets and desired outcomes. 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, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.