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Specialist, Reliability Engineering, Hikari Site/ 光工場 リライアビリティエンジニア(一般社員)

Hikari, Yamaguchi
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On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0126651 Date posted 07/09/2024 Location Hikari, Yamaguchi

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Please note that this job requires business level Japanese language command not only in speaking, but also in business writing and reading.​




”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.


*English follows





•   製造、環境、健康、安全性に対するリスクを最小限に抑える機器、ユーティリティ、施設の設計、保守、技術、イノベーション戦略を適用するチーム及び技術者を指揮する。

•   故障を検出、防止、又は予測する最適な保全戦略を開発することにより、機器の稼働時間を延長し、廃棄物を排除し、資産の寿命を延ばすチーム及び技術者を主導する。

•   設計、操作性、保全における欠陥の原因に対処することにより、機器、ユーティリティ、施設の継続的改善を推進するための信頼性に関する主要な性能指標を測定する戦略を設計するチームと技術者を主導する

•   Leads team and SME who applies design, maintenance, technology and innovation strategies for equipment, utilities and facilities that minimize risks to manufacturing, environment, health and safety

•   Leads team and SME who increase equipment uptime, eliminate waste, and prolong asset life by developing optimized maintenance strategies that detect, prevent, or predict failures

•   Leads team and SME who design strategies to measure key performance indicators for reliability to drive the continuous improvement of equipment, utilities and facilities, by addressing the sources of defects in the design, operability and maintenance


•   メンテナンスエンジニアのチームを管理し、スタッフを育成し、KPIをモニタリングし、継続的な改善を推進する

•   新規又は改良された機器、ユーティリティ及び施設が、設計要件をプロジェクトチームに提供することにより、信頼性、保守性及びアクセシビリティのために設計されていることを確認し、設計プロセス中にレビュー及びリスクアセスメントに参加する

•   装置及び機器のシステム及び機器分類は、適用される手順に従って実施する。

•   予防保全、状態ベースの保全及び予測保全を含め、設備、ユーティリティ及び施設の分類及び重要度に基づいて最適な保全及び校正戦略を設定する。

•   予防保全(PM)計画、校正方法、PM/検査及び校正の頻度/間隔、予備部品リストと保全資材の明細を作成する

•   資産の階層、資産の重要度又はシステム及び機器の分類、主要機器及び予備部品の製造業者及びモデルデータ、予防保全計画、それらの予備部品リスト、及び予備部品の保管レベル情報などの重要なデータがCMMSにおいて正確かつ有効であることを保証することにより、CMMSシステムにおけるマスターデータの管理を提供し、必要に応じて修正を開始する。

•   校正活動における戦略を最適化し、工場シャットダウンの必要性を最小限化又は排除する

•   プラント内の保全プログラムの有効性をモニタリングして継続的改善を推進し、関連するKPIを報告し、最も性能の悪い機器( 「Bad Actors」 )を特定する。DMAIC及びFMEAなどの方法論とツールを適用して 「Bad Actors」 の分析を優先順位付けして実施し、 「Bad Actors」 の改善を特定し、欠陥の原因に対処する是正措置及び予防措置の実施を推進する

•   工場内の主要な機器の故障の根本原因分析を主導し、是正措置及び予防措置の実施を推進する

•   サイトでのプログラムを主導し、機器のライフサイクルと健全性を評価し、老朽化した機器を廃棄・交換する必要が生じた場合の残存寿命と計画を予測する

•   製造/生産担当者、保全及びプロセス/プラントエンジニアリング担当者が必要とした場合、機器に対するトラブルシューティング支援を支援する

•   内部及び外部の監査と査察をサポートする

•   ベストプラクティスと学んだ教訓の共有を通じて、メンテナンスと信頼性のための実践コミュニティに関与する

•   Manages team of Reliability Engineers, develops staff, monitors KPIs and drive continuous improvement.

•   Ensure that new or modified equipment, utilities and facilities are designed for Reliability, Maintainability and Accessibility by providing design requirements to the Project Team and participate in reviews and risk assessments during the design process.

•   Perform system and instrument classification of equipment and instruments following applicable procedures.

•   Set the optimal maintenance and calibration strategies for equipment, utilities and facilities based on their classification and criticality, including preventive maintenance, condition based maintenance and predictive maintenance.

•   Develop the Preventive Maintenance (PM) plans, Calibration methods, PM / Inspection and Calibration frequencies/intervals, and spare parts lists and maintenance bill of materials.

•   Provide stewardship of the master data in the CMMS system by ensuring that critical data such as the asset hierarchy, asset criticalities or system and instrument classifications, key equipment and spare parts manufacturer and model data, preventive maintenance plans, their spare parts lists, and spare parts stocking levels information are accurate and effective in CMMS, and initiate corrections when needed.

•   Optimize the maintenance and calibration strategies to minimize or eliminate the need for plant shutdown days.

•   Drive continuous improvement by monitoring the effectiveness of the maintenance program in the plant, report relevant KPIs, and identify the worst performing equipment (“Bad Actors”); Prioritize and perform analysis of “Bad Actors” by applying methodologies and tools such as DMAIC and FMEA, identify improvements for “Bad Actors” and drive the implementation of corrective and preventive actions that address the sources of defects.

•   As assigned, lead Root Cause Analysis of major equipment failures in the Plant and drive the implementation of corrective and preventive actions.

•   Lead the program at the site to evaluate the lifecycle and health of equipment and forecast the remaining life and plan when aging equipment need to be disposed of and replaced.

•   Assists with troubleshooting support on the factory floor for equipment when manufacturing / production staff, maintenance and process/plant engineering staff require it.

•   Support internal and external Audits and Inspections of the Maintenance Program.

•   Engage in the community of practice for maintenance & reliability through the sharing of best practices and lessons learned.


•   工学学士。3 -5年の関連する工学経験

•   ユーティリティ及び重要システムを含め、試験室及び医薬品の製造並びに支援機器に関する知識を有すること(細胞培養、精製、無菌充填、包装、CIP、SIP、HVAC、プラント及びクリーンユーティリティ)。

•   信頼性中心のメンテナンス(RCM)及び/又は総合的な生産性保全(TPM)の概念を理解し、適用できる。

•   海外チームとやり取りできるビジネスレベルの英語力。

•   B.S. in Engineering; 3 - 5 years of relevant engineering experience

•   Must possess knowledge of laboratory and pharmaceutical production and support equipment, including utilities and critical systems (Cell Culture, purification, aseptic filling, packaging, CIP, SIP, HVAC, plant and clean utilities)

•   Understanding and ability to apply the concepts Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) is desirable

•   Business level English language skills with the ability to communicate with overseas teams.


•   チームと複数の中小規模プロジェクトを同時にリードする能力。

•   プロセス改善又は信頼性工学の分野では、業界関連の認証取得が望ましい。

•   PDCA、LEAN、シックスシグマ/DMAIC、FMEAなどのプロセス改善と信頼性工学の原理、方法論、ツールを理解することが望ましい。

•   資産管理とデータ基準に関する知識を持っていることが望ましい。

•   医薬品の製造管理及び品質管理に関する基準(GMP)について理解していることが望ましい。

•   コンピュータ化保守管理システム(CMMS)の使用に習熟する必要がある。

•   振動解析、流体/油解析、赤外線サーモグラフィ及び超音波のような高度な保全戦略の適用の理解が必要である

•   統計データ解析及びデータ可視化ツールの使用経験があることが望ましい。

•   データサイエンスの手法、機械学習に関する知識があることが望ましい。

•   Ability to lead teams and multiple small and medium projects at the same time.

Additional industry-relevant certification is desirable in the area of process improvements or reliability engineering.

•   Understanding of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA is desirable.

•   Knowledge of asset management and data standards is desirable.

•   Understanding of Good Manufacturing Practices (GMP) is desirable.

•   Familiarity with the use of Computerized Maintenance Management Systems (CMMS) is required.

•   Understanding of the application of advanced maintenance strategies such as vibration analysis, fluid / oil analysis, infrared thermography and ultrasound is required.

•   Experience with statistical data analysis and data visualization tools is desirable.

•   Knowledge of data science techniques, machine learning is desirable.







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.


Hikari, Japan

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Time Type

Full time
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Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

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