Specialist, Packaging Pharmaceutical Manufactuirng/ 注射剤製造オペレーター（包装）（契約社員）

OBJECTIVES/PURPOSE Responsible for designing, developing, and maintaining electrical and automation systems. The successful candidate will work closely with cross-functional teams to ensure that all electrical and automation systems are in compliance with regulatory requirements and industry standards. Project engineering for the Strategic Automation Pillars in the areas of: Automation Security & Integrity Engineering Automation & Control Systems Data Integrity Automation Cybersecurity Automation Solutions & Systems Engineering Functional setups & architectures of systems & components Supervisory Control Structures & Data Mgt. Automation Data Engineering Standard Automation Integration Layer (Shopfloor Systems & Data Integration) Data Channels, HMI, displays & Visuals Historization Automation Data Governance Engineering Data Structures & Contextualization Use Case Owner Liaison Mgt, Technical2Business (and vice versa) translation ACCOUNTABILITIES As a member of the Engineering workstream of the project, provides guidance and leadership to all automation-related activities in accordance with the Global Automation Strategy. In detail, He/she will: Report to the engineering manager. Develop and maintain automation guidelines and standards based on project approved budget and schedule, and ensure compliance Ensure that all automation systems meet regulatory requirements, client specifications, and industry standards and define the user requirements. Ensure compliance with Automation Standard Requirement Specification, Automation Engineering Guideline, compliance, and cybersecurity in the project. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with external design company the procurement strategy packages definition related to its discipline. Review and approve automation documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals.

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.

As a member of the Engineering workstream of the project, provides guidance and leadership to all automation-related activities* in accordance with the Global Automation Strategy. In detail, He/she will: Report to the engineering manager. Develop and maintain automation guidelines and standards based on project approved budget and schedule, and ensure compliance Ensure that all automation systems** meet regulatory requirements, client specifications, and industry standards and defines the user requirements. Ensure compliance with Automation Standard Requirement Specification, Automation Engineering Guideline, compliance, and cybersecurity in the project. Collaborate with other project disciplines to ensure integrated design solutions. Guide and coordinate with external design company the procurement strategy packages definition related to its discipline. Review and approve automation documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. * Automation Security & Integrity Engineering Automation Solutions & System Engineering Automation Data Engineering Automation Data Governance Engineering **

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