コミッショニング＆クオリフィケーション担当　シニアバリデーションエンジニア エンジニアリング部課長代理

募集部門の紹介 医薬品製造工場の設備(建築、機器、空調、配管、電気、計装）に関するオーナーズ・エンジニアリング業務（自社の立場に立ったエンジニアリング業務）を実施している部門です。 職務内容 予備部品管理者/管理者の指示の下、予備部品及び保全資材の受領、保管、移動を含む、効率的かつ効果的な日常の物品管理活動 予備品倉庫/保管室の物理的セキュリティの日常的なモニタリング及びすべてのセキュリティ関連の問題の管理者への報告 Efficient and effective daily warehouse activities, including the receipt, storage, staging and movement of spare parts and maintenance materials under direction of Spare Parts Supervisor / Manager Day-to-day monitoring of physical security in the spare parts warehouse/storeroom and the reporting of all security-related issues to management

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.

製剤設備の予防保全、設備のメンテナンス計画の立案及び実施 製剤製造設備のトラブル時の修理、工程改善活動 製剤製造設備の老朽化による設備更新業務 クオリフィケーション、バリデーション、キャリブレーションの実施および管理

【職務内容】 医療用医薬品やワクチン等の製造設備について以下の業務に従事いただきます。 ・作業指導書に則った製造設備の予防保全 ・保全受託業者への指示、管理・監督業務 ・報告書および記録書の照査 ・保全・修理作業の際に十分な安全対策を実施していることを保証する ・設備のトラブル時の修繕