医薬品メーカー（先発医薬品）

【職務内容】 ステークホルダから要件をヒアリングの上でエンジニアリング会社などと原薬・バイオ製造設備、製剤・包装設備のF/S, FEEDを行いプロジェクトリードとして設備計画を取りまとめる。小規模なプロジェクトでは自身が基本設計を行う場合がある。 設備計画が承認された際には引き続き競争入札の上でEPCを実施してコミッショニング、クオリフィケーションを行いPQ以降の工程を技術/現場/保全部門へ引き継ぐ。 生産設備や用役設備の中長期的な計画を策定・管理を行うことでサイト戦略を立案する 品質保証に関する業務を理解して必要なドキュメントの作成、レビューを行うとともに各域当局、グローバルエンジニアリング組織からのガイダンスを確認して既設設備の評価を行う。 Responsibilities: The department supports the lifecycle (installation, startup, operation, and renewal) of all Hikari facilities. After hearing requirements from stakeholders, conduct feasibility studies and concept designs for formulation/packaging, bio/pharmaceutical production facilities and service facilities, and compile facility plans. The site strategy is developed by formulating and managing mid- to long-term plans for production facilities and service facilities. Planning, drafting, designing, giving production instructions to suppliers, commissioning, and qualification of production facilities for solid and sterile drugs, packaging, or biotechnology and active pharmaceutical ingredients, and guiding the facilities. The candidate will be responsible for the planning, drafting, designing, giving manufacturing instructions to suppliers, commissioning, qualifying, and guiding the equipment.

The Opportunity As a Data Platforms Engineering leader, you'll have a business Impact and direct alignment to the Head of Data Platforms and Architecture vision. The role is a key enabler for strategy to become a Data Driven Enterprise. By connecting with Business Units and Business Functions within Global Business and with their data teams, the data platform lead will strategically architect data, processes, and technology to achieve faster time to market for life saving products. Ultimately, help to make better decisions that improve the quality and efficiency of care for patients. You will develop data driven solutions utilizing current and next generation technologies to meet evolving business needs. You will quickly identify opportunities and recommend possible technical solutions and you will develop application systems that comply with the standard system development methodology and concepts for design, programming, backup, and recovery to deliver solutions that have superior performance, reliability, and integrity. As part of our transformational journey on Data & AI in Operations, we are taking the steps to advance to Data Mesh architecture. The current Datalake exists to give all Operations units access to critical data and analytic tools at pace, accelerating their work on life saving medicines. The vision of EDS is also accelerating Operations’ data strategy of making our data Findable, Accessible, Interoperable, and re-useable. This is being achieved through the creation of a distributed data architecture, management of our data and data products which will sit as a centerpiece of this strategy and the future evolution of Data Science. Responsibilities Create best practices and thought leadership content to be used by the federated delivery teams building data solutions and data products on Enterprise Data platforms that cater to batch, streaming and real-time data. Influence stakeholders at all levels through complex engagement models with the wider cloud ecosystem not limited but inclusive of AWS foundations for Infrastructure and data technologies, Databricks, Informatica, Kafka, Managed File Transfer, and 3rd party applications, ensuring they are excited by the Enterprise Data Services vision and solution strategy. Be a 'champion’ for both customers and colleagues by operating as an expert Engineer and trusted advisor for significant data analytics architecture, design, and adoption and scaling of the Datalake platform. Provide a roadmap for modernizing legacy capabilities inherent to the current platform. Support all data platform initiatives – Data Lake Strategy, Data Engineering and Platform development, Data Governance, Security Models, and Master Data Management. Establish a collaborative engineering culture based on trust, innovation, and a mindset of continuous improvement. Utilize Industry best practices and agile methodologies to deliver solution and extract efficiency through automations in Continuous Development and Continuous Integration. Manages efforts to problem solve for engineering challenges and coordinate with project consultants and delivery/engagement managers. As a leading technical contributor who can consistently take a poorly defined business or technical problem, work it to a well-defined data problem/specification, and execute it at a high level. Have a strong focus on metrics, both for the impact of their work and for its engineering and operations. Understand the Data Platforms investments and create data tools for consumption of services and uncover opportunities for cost optimization to assist the team in building and optimizing our platforms into an innovative unit within the company. Skills and Qualifications Bachelor’s degree or higher in Computer Science/Information technology; or relevant work experience.

職務概要 クリニカルリサーチマネージャーとしての募集となりますが、入社後数年間の経験を経て、ご自身のキャリア志向も踏まえて、将来は柔軟に広く社内の様々な展開で活躍することも可能となります。 【臨床試験におけるオペレーション業務のリーダー】 米国本社カウンターパートと協力し、試験全般の業務業務における日本国内メンバーのリーダー役割を担う ・試験計画、開始準備、実行、終了に亘り、トライアルチームをリードする ・チームメンバーや各種ベンダーが行う業務が遅滞なく進行する取り方を考える ・試験にかかるコスト、主要マイルストン、リスク等のマネジメントを行う ・ CRA （CRO含む）の相談窓口として、施設レベルの課題を解決する ・試験を通じた文書管理コンプライアンス、各施設における品質を守る

OBJECTIVES: Deliver specialized HR support to Corporate Function leaders and employees within an assigned location or functional area Work alongside HR Business Leaders (HRBLs), embedded Talent Leads, People Advisory Group (PAG), Centers of Excellence and Innovation (COEIs), and Function/Business Leaders to contextualize, deploy and embed the Function’s respective “People” agenda in the areas of organization capabilities & effectiveness, engagement & belonging, lifelong learning, talent management & development, talent acquisition and people analytics & insights Steward of delivering an exceptional people experience. Partner with Managers and employees to enable team and individual effectiveness. Manage escalated situations and establish feedback loops. Seamless implementation of cyclical HR processes ACCOUNTABILITIES: Deliver an exceptional people experience within Corporate Functions, so everyone can fulfil their potential and enable mission Contextualize, deploy and embed respective Corporate Function “People” agendas, in the areas of organization capabilities & effectiveness, engagement & belonging, lifelong learning, talent management & development, talent acquisition and people analytics & insights Active role in ensuring assigned leader, team and/or functional areas’ effectiveness. Facilitate assimilation of new leaders. Coach and support individual and team development. Identify needs, develop and deploy solutions. Elevate the group’s performance Deploy and embed talent management and learning programs (e.g. intern, early career rotation programs, talent reviews) in partnership with Corporate Function Talent Management lead and HRBLs Consultation on performance management and development planning efforts which cover all employees within assigned group Deploy and embed local Talent Acquisition plans. Partner with Corporate Function TA leads to provide HR support in areas of local brand management, process awareness, interviewing/selection and metrics/KPIs Work alongside Corporate Function Compensation COEI Lead to manage Total Rewards processes for assigned group, including job descriptions, levelling, Deliver an exceptional people experience within Corporate Functions, so everyone can fulfil their potential and enable mission Contextualize, deploy and embed respective Corporate Function “People” agendas, in the areas of organization capabilities & effectiveness, engagement & belonging, lifelong learning, talent management & development, talent acquisition and people analytics & insights Active role in ensuring assigned leader, team and/or functional areas’ effectiveness. Facilitate assimilation of new leaders. Coach and support individual and team development. Identify needs, develop and deploy solutions. Elevate the group’s performance Deploy and embed talent management and learning programs (e.g. intern, early career rotation programs, talent reviews) in partnership with Corporate Function Talent Management lead and HRBLs Consultation on performance management and development planning efforts which cover all employees within assigned group Deploy and embed local Talent Acquisition plans. Partner with Corporate Function TA leads to provide HR support in areas of local brand management, process awareness, interviewing/selection and metrics/KPIs Work alongside Corporate Function Compensation COEI Lead to manage Total Rewards processes for assigned group, including job descriptions, levelling, offers, mobility, annual performance & reward calibration. Ensure Total Rewards are locally competitive and aligned with local / regional needs In partnership with Regional PAG Employee Relations (ER) specialists (where country PAG exists), support employees and managers on ER matters. This includes conflict resolution, individual performance plans, investigations and general counselling. Mitigate risk for company, ensure objectivity, consistency, sound judgment and compliance Implement restructuring and reorganization plans with keen eye toward project management, change management and local nuances within assigned group Steward of the employee experience. Handle queries escalated from People Solutions. Ensure effective feedback loops between employees, leaders, People Solutions, People Advisory Group (PAG) and COEIs. Translate engagement survey feedback into insights and action plans. Develop and deploy employee engagement and communication plans for assigned groups. Manage cyclical global talent management processes such as succession/talent planning, performance management and compensation Deliver high quality people insights that matter locally e.g. stay/exit interviews, turnover, hiring trends, employee relation patterns. Recommend innovative solutions and proactively course correct as required Establish forward looking workforce plan for assigned group including hiring, succession and talent pipeline for pivotal roles Engage in collaborative relationships with HRBLs, other HR Partners (HPs), People Solutions, PAG, COEIs and other Functions such as Ethics & Compliance, Finance, Legal, IT, or Security to develop HR processes, initiatives and solutions that make a positive impact when deployed and embedded within the Corporate Functions As part of the Global Corporate Function HR Team, help shape our overall direction and continuously raise the bar on value/impact we deliver. Identify patterns and root cause solutions that are best for the Function and enterprise Participate in Global HR projects as required. Apply knowledge of how Corporate Functions work to co-create new ways of working that deliver results