Automation Data Engineer/ オートメーション データエンジニア（一般社員）

【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

OBJECTIVES/PURPOSE Coordinating the engineering activities of about 1000 Oku Yen investment at the Osaka Site, Japan, to implement an end to end manufacturing facility for Plasma Derived Therapy products including Drug Substance (DS), Drug Products (DP), Inspection and Packaging (I&P) and a Cold warehouse. ACCOUNTABILITIES Develop and manage project budgets, ensuring that all expenditures are in accordance with approved budgets. Manage project risks, ensuring that risks are identified, assessed, and mitigated in a timely manner Provide regular project status updates to senior management and other stakeholders. Ensure compliance with all applicable regulations, guidelines, and policies. Provide regular management up-dates and act as an enabler for individual project teams. Use project management methodologies and skills to manage the capital project across organizational boundaries and is responsible for its successful delivery. Ensures the project is conducted at the highest quality, within time and budget, and that the risk level and stakeholder expectations are managed. Ensures adherence to the GMS GOP - Planning and Execution of Capital Investment Projects Coordinates and supervises project execution related activities, from initiation to close out and successful hand-over. Leads a cross functional team of internal and external specialists. Responsible for meeting project scope requirements, schedule requirements, and costs. Interfaces with major projects/initiatives at the specific plant. Transfers best practices across functions and business units as well as other sites. Ensures compatibility and consistency with the existing organization and industry standards (PMM, cGMP, GEP, etc.) Coordinates with all stakeholders, facilitates problem solving sessions and or other planning sessions, and makes adjustments to the project in alignment with the overall business strategy. Responsible for the adequate utilization of all quality systems as defined by Procedures within the project organization. Ensures appropriate safety measures are taken to prevent injuries and minimizes safety risks. Ensures readiness for inspections together with quality organizations. Ensures compliance with rules and regulations of procurement and accounting.

【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.

光工場の新設工事ならびに改良工事における、滅菌バリデーション業務を実行します。 ・医薬品製造設備の洗浄プロセスを評価し、バリデートする責任を負います。 ・主な業務には、プロトコール作成、バリデーション作業の調整、バリデーションの実施、最終報告書の作成、最終バリデーションパッケージの作成、プロジェクト計画の作成が含まれます。 ・イニシャルバリデーションと再バリデーションの両方の責任を有します。さらに、製造上の課題の調査を行い、プロセスの改善を評価し、報告文書を作成します。 ・規制当局への文書提出、またはそれをサポートし、内部および外部の査察の際、必要に応じて利用できるように保管・管理します。 上記の業務を製造部門、エンジニアリング部門、薬事部門、品質管理部門、品質保証部門と日々連携して業務を行います。