設備保全エンジニア（機械）

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Job Description

OBJECTIVES/PURPOSE

· 予防保全、計画保全、事後保全の計画・実施の結果を踏まえてライフサイクルにわたり安定的な

設備稼働を確保する。

Ensure stable equipment operation throughout the life cycle based on the results of preventive

maintenance, planned maintenance, and corrective maintenance planning and execution.

· 製造設備のプロセス及び保全の技術的な専門家のリーダーとして部内と他部門（製造及び品質管

理部門等）の連携結束の役割を担う。

As a technical expert leader of manufacturing equipment process and maintenance, play a role of

coordinating and coordinating within the department and other departments (Manufacturing and

Quality Control departments, etc.).

· 業務生産性を向上させる改善及び変更実施のためのサポートを提供する。

Provide support for improvements and change implementations that improve operational produc-

tivity.

· サイトの生産能力拡大のために新規設備及び新プロセス、設備更新等の計画・実行をリードす

る。

Lead the planning and execution of new equipment, new processes, equipment renewals, etc. to

expand the production capacity of the site.

· 監督当局査察時、保全担当のSME（Subject Matter Expert）として査察官の対応にあたり、保全

の状況などについて十分な知見の下で説明を行い、理解をえることに努める。

At the time of inspection by the supervisory authority, as an SME (Subject Matter Expert) in

charge of maintenance, when responding to the inspector, explain the status of maintenance with

sufficient knowledge and strive to gain understanding.

ACCOUNTABILITIES

· 無菌製剤、包装設備、ユーティリティ等の機械保全業務の担当者。

Resposible for mechanical maintenance operations of sterile formulations, packaging equipment,

utilities, etc.

· 製剤・充填システムに関して他のプロセス制御エンジニアおよび / または技術者に助言を与え指

導することが期待される専門家 (SME)。

An expert (SME) who is expected to advise and guide other process control engineers and / or

technicians regarding formulation and filling systems.

· 予算算出、保全計画の作成および計画通りの実施、管理、計画の最適化を行う。

Calculate budget, creation of maintenance plans, implementation as planned, management, and

optimization of plans.

· 工場の設備とシステムのトラブルシューティング、生産・包装用機器の修理作業を行う。

Troubleshoot factory equipment and systems, repair production and packaging equipment.

· 現場に立ち、既存設備を改善して生産停止時間を最小限にするための技術を検討・推奨する。必

要に応じて、既存設備の改善方法を提案する。

Stand on site and consider and recommend technologies to improve existing equipment and mini-

mize production downtime. If necessary, propose improvement methods for existing equipment.

· 製造エリア全体での適格性評価作業、再バリデーション作業のサポートを行う。

Support qualification and revalidation work for the entire manufacturing area.

· 逸脱や故障発生時、根本原因を特定し、是正措置の推奨事項を策定し確実に完了させるためのフ

ォローアップを行い、変更管理、逸脱、CAPAに関する対応が適切に行われることを確認する。

In the event of a deviation or failure, identify the root cause, formulate recommendations for cor-

rective action, and follow up to ensure completion, and ensure appropriate handing of change

control, deviations and CAPA.

· 保全に関するSAPデータ の入力、管理を行う。

Enter and manage maintenance-related SAP data.

· 保全に関する要領書類のドキュメントオーナーとして、文書の制改訂、管理、教育を行う。

As document owner of maintenance prodedures, revise and manage documents, and provide

training.

· 社外保全委託先の管理を行う。

Manage external contractors for maintenance.

· 社内・社外監査や査察において、保全のSMEとして保全プログラムや実施状況について十分な

知見の下で説明を行う。

At internal/external Audits and Inspections, as a maintenance SME, explain the maintenance pro-

gram and implementation status based on sufficient knowledge.

· 上長特命事項を遂行する。

Carry out superior special matters.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical

knowledge)

· 業務遂行に必要な指示書を読んで従うことができ、会話 / 文書でのコミュニケーション能力を有

する。

Can read and follow the instructions necessary for business execution, and has high communica-

tion skills in conversation / writing.

· Word、Excelなどの標準的なオフィスソフトウェアおよび SAP_PMを扱える。

Familiar with standard office software such as Word, Excel, PowerPoint and SAP.

· 電子メールシステムとイントラネットを操作してコミュニケーションを図ることができる。

Possible to reduce the communication by operating the e-mail system and intranet.

· 充填ライン、高圧蒸気滅菌機、プロセスタンク、CIP / SIPシステムなどを含むが、これらに限定

されない基本的な医薬品製造装置の知識があることが望ましい。

Knowledge of basic pharmaceutical manufacturing equipment, including but not limited to filling

lines, high pressure steam sterilizers, process tanks, CIP / SIP systems, etc., is desirable.

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing

change)

· 各個人の意見やニーズを尊重しつつ、効果的なコミュニケーションやフィードバックを行うこと

ができる。

Effective communication and feedback while respecting the opinions and needs of each individual.

· 目標に対する理解をチームで共有し、共通のゴールを達成するために、組織全体にわたって有意

義な人間関係を構築する。

Build meaningful relationships throughout your organization to share your understanding of your

goals with your team and to achieve common goals.

· チームへの貢献をより高めるために、自己の認識と行動を上達し、スキル向上と行動改善に積極

的に取り組む。

Improve self-awareness and behavior, and actively work to improve skills and behavior in order to

contribute more to the team.

· 持続的な成長を常に達成することができるように、自己の成長を追求する。

Pursue opportunities to grow yourself and your members so that you can always achieve sustain-

able growth.

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in deci-

sion-making, complexity of decisions, impact of decisions, problem-soliving)

· 生産力拡大と新製品の開発プロセスを支援するため、資本設備への支出計画 (費用、タイミン

グ、利益、リソース) をサポートする。

Develop and support spending plans (costs, timing, profits, resources) for capital and equipment

to support productivity expansion and new product development processes.

Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external rela-

tionships)

· 対人関係スキルを持ち、チームで効果的に仕事ができる。

Have good interpersonal skills and be able to work effectively as a team.

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

· 期待される寿命と信頼性に関して既存の施設、設備およびシステムを評価する。

Evaluate existing facilities, equipment and systems for expected life and reliability.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

· 製造設備、ユーティリティなどの構造、機能、動作および保全に対する知識を有する。

Have knowledge of structure, function, operation and maintenance of munufactruing equipment

and utility.

ADDITIONAL INFORMATION

· 保全技能士（機械系）資格取得を推奨

Recommended for maintenance technician qualification (Mechanical).

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company’s discretion.

• It is possible the department and workplace may change at the company’s discretion.

Locations

Osaka (Juso), Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time