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J&J Family of Companies [Janssen] Supply Chain, Maintenance and Reliability Engineer, Fuji Factory in Shizuoka, Japan

[Janssen] Supply Chain, Maintenance and Reliability Engineer, Fuji Factory - 2406168640W

Description

安定的な生産を継続するために検査および包装ラインのメンテナンスおよびエンジニアリングを行う。

Responsible for the maintenance and engineering of inspection and packaging line to continue the

operation with good condition.

・ GMP/GCTP

・ Japanese laws and regulations

・メンテナンスエンジニアは富士工場の生産設備を維持し、円滑な生産をサポートする。（トラブルシューティングを含む）

Maintenance engineer is keeping the Fuji-site equipment’s, supporting to stable operation.(Including Troubleshooting )

・ 突発的な機械トラブルの対応。生産のサポート業務。Response to unexpected machine troubles and

production support.

・ 品質不良の対応。エンジニアとして参画し、技術的サポートをする。(点検業務）Response to unexpected quality

issue and technical support.(Inspection)

・ 定められた年間点検計画に従い、点検を実施する。Conduct annual inspection based on annual

inspection plan.

・ 生産設備の部品消耗を早期発見し、予防保全を実施する。（校正）Early detection of parts damage in

production equipment and preventive maintenance.(Calibration)

・ 定められた年間校正計画に従い、校正を実施する。（予備部品）Conduct calibration based on calibration plan.

(Spare parts)

・ 生産停止のリスクに応じて、各設備に対し必要な部品を常時保有できるように管理する。（適格性評価）Conduct risk

assessment of production stop and Storage the Critical parts of each equipment’s.(Qualification)

・ 富士工場の生産設備に対して発生する変更内容に対して必要な Qualification を実施する。Conduct

qualification for change that occur to equipment’s at the Fuji-site.

・ 新製品上市に伴い、必要な Qualification を実施する。（設備導入/改善 ）Conduct qualification for launch NPI.

(Machine Introduction/Improvement)

・ さらなる安定稼働のために設備の導入または改善を行う。Machine introduction or improvement for

further stability operation.

・ 新規設備の導入に伴い、必要な Qualification を実施する。Conduct qualification for new machine

introduction.

・ プロジェクトオーナーとして、プロジェクト全体(スケジュール/予算/アクティビティ)、変更管理

を管理する。Lead the overall project(Schedule/Budget/Activity) and Change control as project owner.

(機械安全 Machine safety)

・ 生産設備の安全性を評価し、常に維持しなければいけない。Production equipment’s of safety are

assess and must always be kept.

・ JJ standard を熟知し、安全仕様を満たした設備を導入する。Understand JJ standard and must

introduce the machine of full meet safety specification.

(SME)

・ TV-FRM-47456 「富士工場 SME リスト SME Assignment List at Fuji site」においてSME に任命され

た際はその業務を遂行する。Perform duties as SME when assigned in accordance with TVFRM-47456

"SME Assignment List at Fuji site"

Qualifications

＜教育/経験　Education and Experiences＞

・Above University Completion degree (either Machine Engineering or Electronic Engineering major)

・Knowledge and experience of LEAN production （6σ, 5whys, FMEA, RCA, ME2, OEE management, etc)

・GMP/GCTP based thinking skill is better to have (in other regulated industry such as cosmetics, food/beverage/medical device etc is better)

＜知識、資格、及び技能 Knowledge, Qualification and Skills＞

・Project management knowledge and experience

・Strong communication skill for other division and operators

・Document creation ability such as meeting minutes, technical documents, etc

・English communication skill (email reading and writing level with translation tool, no conversation skill is required)

  • This position has night shift for a whole week in every 5-6 week (20:00PM to 3:00AM)

Primary Location Asia Pacific-Japan-Shizuoka-Sunto-Gun

Organization Janssen Pharmaceutical K.K. (7195)

Job Function Repair & Maintenance Engineering

Req ID: 2406168640W

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