Engineer (Process or Automation)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsible for installation, modification, Kaizen of both production equipment and controlling tool/system for pharma products.

• Responsible for commissioning, qualification, validation, etc., that includes appropriate documentation, verification and approval from Engineering professional standpoint both production equipment and controlling tool/system for pharma products.

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

• Responsible for CAPA (Corrective Action, Preventive Action) by complying with Deviation management and Change control procedures and process, when any trouble happens.

• Responsible for corresponding internal / external audit and delivering appropriate plan/actions to ensure products quality as Audit action and Site GMP Plan

• 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:

• Experience to supervision of direct reports

• Automation / control system experience

Essential skills and license (mandatory for hiring)

• Engineering degree at university

職務内容/Job Responsibilities:

• エンジニアとして医薬品製造ラインの導入・トラブルシューティング・改善、また生産管理ツールの導入や改善に責任を持つ

• ラインや生産管理ツールの導入や改善におけるコミッショニング、クォリフィケーション、バリデーション等のドキュメントの作成、照査、承認に責任を持つ

• 日本イーライリリー製造本部におけるグローバルの品質基準およびエンジニアリング基準の実践

• 逸脱および変更管理の手順に従った、トラブル発生時のCAPA（Corrective Action Preventive Action）に責任を持つ

• 内部/外部の監査に対する対応、および関連するSite GMP Planの実施に対して責任を持つ

• プロセスの自動化・デジタル化及び生産ラインや関連設備の制御システムの設計、プログラミング、仕様作成、業者との調整・実行

必須経験（/Required Experience (mandatory for hiring)

• 製造に関わるエンジニアの経験（新しい設備、Process導入の経験）。

• 語学力（日本語：ビジネス以上、英語：日常会話以上）

望ましい経験/Desirable Experience:

• 直属の部下を持った経験

• 生産設備の制御設計・設備自動化に関する業務経験

• 医薬品の製造もしくは近い業種に関わるエンジニアの経験

必須応募資格/Essential skills and license (mandatory for hiring)

• 工学系の学部卒以上

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