Manager, Process Engineering/ Capital Project Management/ プロセスエンジニア（課長代理）

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Job Description

Please note this job requires business level Japanese in speaking, writing, and reading.

２４０年の歴史の中でタケダでは常に患者さんを中心に考え、世の中（世界中）の人々により健やかで輝かしい未来をお届けすることを目指してきました。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組んで取り組んでいます。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。

【募集部門の紹介】
光工場（山口県）エンジニアリング部は、医薬品製造工場の設備(建築、機器、空調、配管、電気、計装）に関するオーナーズ・エンジニアリング業務（自社の立場に立ったエンジニアリング業務）を実施し光工場のすべての設備のライフサイクル（導入立上げ・運用・更新）を支えている部門です。

Introduction of Department:

The Engineering Department of the Hikari Plant (Yamaguchi Prefecture) is a department that supports the life cycle (installation, start-up, operation, and renewal) of all facilities at the Hikari Plant by performing owner's engineering work (engineering work from the company's standpoint) related to facilities (construction, equipment, air conditioning, piping, electricity, and instrumentation) at the pharmaceutical manufacturing plant. This department supports the life cycle (installation, start-up, operation, and renewal) of all facilities at Hikari.

【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.

【必須経験・スキル】

 機械工学または電気・電子工学エンジニアリングの学位、若しくは準ずる知見を有している。

 化学/バイオプラント設備、生産機械設備、電気、電気制御、オートメーションシステム、物流機器/システム、クリーンルーム設備等に関する技術知識。

 10年程度の医薬品製造、食品、化粧品、化学製品などの製造業での設計の職務経験。

Required Experience/Skills:

• Degree in mechanical engineering, architectural engineering, or electrical/electronic engineering, or equivalent knowledge.
• Technical knowledge of production machinery and equipment, chemical/biotech plant equipment, electricity, electrical controls, automation systems, logistics equipment/systems, clean room equipment, etc.
• 10 years of experience in design and maintenance in pharmaceutical manufacturing or other manufacturing industries.

【望ましい職務経験・資格】

下記業務の経験者。または、それに相当する業務の経験者。

 製薬企業、もしくは製薬・化粧品企業等に関連する業務に携わった方で、薬事法、GMP, GLP, HACCPなどの規制関連知識

 医薬品、化粧品、食品工業等で製造/包装設備、その他生産用設備、建物設備の機械分野、あるいは計装・制御・電気分野に関する設備全体の企画立案・設計・コーディネート・建設プロジェクトの実務経験や、バルクプラント建設プロジェクトでのエンジニアリング業務や設備保全・管理の実務経験のある方が望ましい。

 英語の基本的なコミュニケーション能力と読み書き能力。

Preferred Work Experience and Qualifications:

• Experience in the following tasks or equivalent. Experience in the following tasks or equivalent tasks.
• Knowledge of the Pharmaceutical Affairs Law, GMP, GLP, HACCP, and other regulations.
• Experience in planning, designing, coordinating, and construction projects for manufacturing/packaging facilities, other production facilities, mechanical field of building facilities, or instrumentation/control/electrical field of facilities in pharmaceutical, cosmetics, food industry, etc., or engineering work in bulk plant construction projects, or facility maintenance/management is desirable. Experience in engineering work or facility maintenance and management in bulk plant construction projects is desirable.
• Basic communication skills and the ability to read and write in English.

【あれば望ましい資格・期待する資格】 ※必須ではありません。

 エネルギー管理士、公害防止管理者、電気主任技術者(第3種)

 高圧ガス製造保安責任者、冷凍機械保安責任者、消防設備士など。

Desirable qualifications and expected qualifications: *Not required.

• Energy manager, pollution control manager, chief electrical engineer (3rd class), first-class architect.
• High-pressure gas production safety supervisor, refrigeration equipment safety supervisor, firefighting equipment supervisor, etc.

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.

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