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<製造本部>Lead Engineer/担当-担当課長/西神工場
full-timeKōbe

Summary

Location

Kōbe

Type

full-time

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About this role

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Job Responsibilities:

• Oversight and support of asset delivery and commissioning/qualification activities to ensure that the equipment /system is appropriate for the intended purpose. 
• Ensure changes, maintenance and other interventions do not adversely impact the qualified state of equipment. 
• Working cross-functionally to oversee the ongoing asset qualification monitoring of direct impact facilities, utilities, and equipment systems. 
• Approve technical documents and release statements in qualification packages in accordance with the requirements and /or local procedures. 
• Provide guidance on key elements of return to service requirements for equipment after interventions, such as maintenance. 

• Deploy Lilly Manufacturing’s global Engineering and Quality standard into the site.

• Responsible for CAPA (Corrective Action, Preventive Action) in compliance with Deviation management and Change control procedures.

• Represent the Engineering function in internal / external audits and delivery of relevant action plans.

• Automation System architecture / network

• Understanding of equipment specific code and/or control system technologies

Required Experience (mandatory for hiring)

- Engineering experience (new equipment and/or process installation) in manufacturing

- English communication (Read/Write and Conversation)

Desirable Experience:

  • Supervisory experience (direct/indirect)
  • Automation / control system experience
  • Equipment reliability and performance monitoring

Essential skills and license (mandatory for hiring)

- Engineering degree or >10 yrs industrial manufacturing experience

職務内容/Job Responsibilities:

  • 設備納入の適格性確認活動監督・支援により、装置/システムが用途に適合していることの確認。

  • 変更、保守、その他の介入によって装置のQualified Stateに影響がないように、評価・監督する。

  • 製品品質に直接影響を与える施設、ユーティリティ、装置、システムの継続的な適格性モニタリングのため、部門横断的に業務を行う。

  • 要件および手順に従って、適格性パッケージ内の技術文書を承認する。

  • 保守などの介入後、装置のReturn to Serviceの指導を行う。

  • Lilly Manufacturingのグローバルなエンジニアリングスタンダードをサイトプロセスに反映させる。

  • 逸脱管理および変更管理手順に従って、CAPA(是正措置、予防措置)を担当する。

  • 内部/外部監査においてエンジニアリング部門を代表し、関連するアクションプランを遂行する。

  • 自動化システムのアーキテクチャ/ネットワーク

  • 装置固有のコードおよび/または制御システム技術の理解

必須経験:

  • 製造業におけるエンジニアリング経験(新規装置および/またはプロセスの導入)
  • 英語でのコミュニケーション能力(読み/書きおよび会話)

望ましい経験:

  • 監督経験(直接/間接)
  • 自動化/制御システムの経験
  • 装置の信頼性および性能モニタリング

必須スキルおよび資格(採用必須):

  • 工学系の学部卒以上、または10年以上の産業製造経験

【給与】 当社規定により優遇します

【諸手当】住宅手当、通勤交通費など

【昇給】有り

【賞与】年一回(翌年3月)

【勤務時間】8451730

【時間外手当】”担当職”のみ支給

【清算制フレックス勤務】適応あり。フレキシブルタイム:5時~22時内で勤務。(ただし、一斉休憩を除く)1日の必要最低労働時間:4時間(半日休暇時は2時間)一斉休憩:12時~13

【在宅勤務制度】有

【休日休暇】完全週休2日制(土・日曜日)、祝日、クリスマス、年末年始・夏期

*年間休日125日、年次有給休暇、慶弔等

【保険】雇用・労災・健康・厚生年金保険

【定年制】有(60歳)                                                                                                    

【継続雇用制度】:有(65歳まで)                                                                                                        

【有給休暇】                                                                                                    

  • 1日に付与さる。入社日にかかわらず、その年の1231日をもって、勤続年数が1年経過したものとみなし、翌年11日に翌年度の年次有給休暇が付与される。                                                                                                   

    入社月      1-6月  7月  8月  9月 10月  11月  12          

                     10        5       4       3       2      1       0  

                                                                                                           

【試用期間】 6か月間  試用期間中での賃金の違いはございません

Eli Lilly Japan社員の方へ、

社内公募へ自ら応募して異動/転勤する場合のサポート内容はビジネスニーズに基づき異動/転勤する場合と異なりますので、

あらかじめ応募にあたっては、詳細は以下リンク先にある情報をご確認とご理解を頂くようお願いいたします。

https://now.lilly.com/landingoverview/JP-change-in-career-system/JP-changes-in-my-career-faqs

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

Other facts

Tech stack
Engineering,Asset Delivery,Qualification Activities,Cross-Functional Collaboration,Technical Document Approval,Return to Service Guidance,Global Engineering Standards,CAPA Management,Internal Audits,Automation Systems,Control Systems,Equipment Reliability,Performance Monitoring,English Communication,Supervisory Experience,Manufacturing Experience

About Lilly

We're a medicine company turning science into healing to make life better for people around the world. It all started nearly 150 years ago with a clear vision from founder Colonel Eli Lilly: "Take what you find here and make it better and better." Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing science to solve some of the world's most significant health challenges.

General Information and Guidelines:
When you engage with us on LinkedIn, you're agreeing to these Community Guidelines: https://e.lilly/guidelines.

If you have questions about a Lilly medicine, contact The Lilly Answers Center at 1-800-Lilly-Rx (1-800-545-5979) Monday through Friday, excluding company holidays.

Team size: 10,001+ employees
LinkedIn: Visit
Industry: Pharmaceutical Manufacturing

What you'll do

  • The Lead Engineer will oversee asset delivery and qualification activities to ensure equipment is suitable for its intended purpose. They will also manage ongoing asset qualification monitoring and represent the engineering function during audits.

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Frequently Asked Questions

What does a <製造本部>Lead Engineer/担当-担当課長/西神工場 do at Lilly?

As a <製造本部>Lead Engineer/担当-担当課長/西神工場 at Lilly, you will: the Lead Engineer will oversee asset delivery and qualification activities to ensure equipment is suitable for its intended purpose. They will also manage ongoing asset qualification monitoring and represent the engineering function during audits..

Why join Lilly as a <製造本部>Lead Engineer/担当-担当課長/西神工場?

Lilly is a leading Pharmaceutical Manufacturing company.

Is the <製造本部>Lead Engineer/担当-担当課長/西神工場 position at Lilly remote?

The <製造本部>Lead Engineer/担当-担当課長/西神工場 position at Lilly is based in Kōbe, Hyogo Prefecture, Japan. Contact the company through Clera for specific work arrangement details.

How do I apply for the <製造本部>Lead Engineer/担当-担当課長/西神工場 position at Lilly?

You can apply for the <製造本部>Lead Engineer/担当-担当課長/西神工場 position at Lilly directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about Lilly on their website.