Hikari TAKEDA PHARMACEUTICALS AMERICA, INC.
Skills


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.

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Job ID R Date posted 10/30/2025 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's Privacy Notice and 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

OBJECTIVES/PURPOSE

工場のオートメーションシステム(Historian, Standard Automation Integration Layer-SAIL, SCADA, BMS, EMS, DCS)に関するサポート・初期トラブル対応を実施する。
上記には関連システム(MES、Unique product identifier-UPI等)とのインターフェイスについての対応も含む。
バリデートされた状態が維持されていることを確認するための周期的レビュー、逸脱調査サポート、CAPAの実行及び変更の実行もサポートする。
医薬品製造のための変更管理に関する基礎概念を遵守し実行する責任を持つ。
システム関連の仕様、SOPの制改訂をサポートする。
システムを最新に保つためソフトウェアのライフサイクル活動をサポートする。

Accountabilities

オートメーションシステムの運用に関する専門家である。
オートメーションシステムの教育を含むユーザー管理の責任を持つ
オートメーションシステムの日常点検、月例点検、自己点検の責任を持つ
オートメーションシステムのバックアップ、ライセンス、パッチ管理の責任を持つ
現地オートメーションシステムの他システムとのインターフェースを含む初期トラブル対応
平日昼間の現地対応ならびに夜間の電話対応
必要に応じた休日夜間の現地対応
バリデートされた状態が維持されていることを確認するための周期的レビューの実施
逸脱発生時の調査作業
是正措置・予防措置対応作業


DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise

光工場地区の様々なオートメーションプラットフォーム(DCS、SCADA、BMS、EMS、OSI社PIシステム、KepwareOPC)の維持、管理、保守、トラブル対応に関する十分な知識と経験を有す。
プロジェクト管理、生産活動ならびにMES、ヒストリアン、UPI、包装工程に関する幅広い知識と経験
電気、デジタル、自動化、ITなどの基礎知識
原薬、固型剤、無菌製剤、無菌充填、バイオ医薬、ワクチン、検査、包装に関する基礎知識
GMP、特にCSVとALCOAに関する見識

Leadership

旧来の方法を最善のものに改変する
生産トラブルに際し適時最速で技術的対策を講じる

Decision-making and Autonomy

組織効率の改善、潜在化している問題の解決方法の発見、必要とされる危機管理を見極める
アイデアを明確に説得力と確信を持って発信する

Interaction

関連部署との主要な事象・問題に対応する窓口
他部門とのチームレベルの調整

Innovation

効率的で安価な保守を推進する
自動的、継続的な運用を推進する
予測的システム保全を推進する

Complexity

IT部門と共同でオートメーションシステムの保守計画を設定する
グローバルエンジニアリング・IT部門と共同でシステムリスクアセスメントを含むオートメーションの資産ライフサイクルを設定する

Education, Behavioural Competencies And Skills

工学系の学士もしくは修士
7年以上のオートメーションエンジニアの経験を含む10年以上の製薬業界におけるエンジニアリングの経験
ビジネスレベルの英語・日本によるコミュニケーション、リーディング・ライティングのスキル必須
組織人材管理の経験

Preferred

海外勤務経験
オートメーション保守の経験

Additional Information

本ポジションは経験豊富な候補者に GMP 製造とオートメーションのエンジニアリングベストプラクティスを確立する重要な機会を提供するものである。
出張あり。
この職務記述書は、職位に必要なすべての義務と責任を完全に網羅できるような構成にはなっておりません。

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

Hikari, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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