Senior Validation SME, Commissioning

6時間前

Hikari Takeda

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Job Description:
タケダでは、常に患者さんを中心に考え、その生活を豊かにするためにイノベーションを推進しています。そして、従業員一人ひとりにそれぞれの能力と熱意に応じた成長の機会を提供することにも取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。


タケダは4万7千人以上の従業員が、54以上の国や地域で働くグローバルな企業です。すべての従業員が世界中の人々の生活をより良いものにしたいという信念をもち、そしてタケダイズム(誠実:
公正・正直・不屈)を日々の業務で体現しています。私たちは、1781年から続く研究開発型の製薬企業としての伝統のもと団結し、優れた医薬品の創出を通じて、人々の健康と医療の未来に貢献することをミッションとして掲げています。

【募集部門の紹介】:

光工場(山口県)エンジニアリング部は、タケダのグローバル基幹工場である光工場の医薬品製造・研究設備(生産・研究設備、空調、配管、電気、計装)に関するエンジニアリング業務を実施する部署です。

【職務内容】:

医薬品製造設備や工場建屋の新設工事ならびに改良工事における、クオリフィケーション業務を担当します。

担当工事のクオリフィケーション責任者として、医薬品製造設備、重要なシステム(ユーティリティ)や施設を検査し、適切な仕様を満たしているかを評価します。

以下の主な業務に従事いただきます。

プロトコール作成
クオリフィケーション作業の調整
クオリフィケーションの実施
クオリフィケーション報告書の作成

上記業務を実行するにあたり、製造部門、エンジニアリング部門、品質管理部門が日々連携して業務を行います。

【必須要件】:

・医薬品、化粧品または食品業界において設備導入またはクオリフィケーション業務の経験

・プロトコールやSOPの作成の経験

・FDAおよび他の規制当局との直接的または間接的にやり取りした経験

【望ましい要件】:

・大卒以上(工学系または科学系分野)

・バリデーション業務の実務経験

・洗浄プロセス、滅菌プロセス、コンピュータ化システムおよび制御システム

(Allen-Bradley PLC、Delta V、BAS、Siemensなど)に関する経験


Takeda Compensation and Benefits Summary:
Allowances Commutation, Housing, Overtime Work etc.
Salary Increase Annually, Bonus Payment Twice a year
Working Hours Headquarters (Osaka/ Tokyo , Production Sites (Osaka/ Yamaguchi , (Narita , Research Site (Kanagawa
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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