Job Description Summary
Support design, implementation, and maintenance of automation systems in projects and site operations.プロジェクトおよび現場運営におけるオートメーションシステムの設計、導入、メンテナンスをサポートする。Job Description
Major Accountabilities
- Control of room temperature, humidity, and pressure.
- Manage of materials (shipping volume, usage fees)
- Support internal and external audits.
- Develop & implement Coding / Recipes (DCS / Scada / PLC's / Control Networks)
- Manage operations for (OT) systems, tools, and applications, ensuring their stability and integrity, while meeting customer service levels.
- Perform GMP risk assessments (incl. Sensors SR)
Requirements:
- At least 3 years' experience in GMP related work
- At least 3 years' experience in build-up facility system ( any Industry)
- Must be proficient in global and local procedures for operations, maintenance and development.
- Experience with OQ, PQ, DQ, IQ, PV and other documentation.
- Communications skills essential.
- Skills in C&Q within the automation (CSV).
- Fluent level of Japanese and business level English language skills.
- Academic qualifications not required.
- Oversea business trip required few times annually
- Engineering experience in automation in the chemical or pharmaceutical industry desirable.
主な役割責任
- 室温、湿度、気圧の管理。
- 資材の管理(出荷量、使用料)。
- 内部および外部監査のサポート。
- コーディング/レシピ(DCS/Scada/PLC/制御ネットワーク)の開発および実装。
- (OT)システム、ツール、アプリケーションの運用を管理し、安定性と完全性を確保しつつ、顧客サービスレベルを満たす。
- GMPリスクアセスメントの実施(センサーSRAを含む)
応募要件
- GMPに関わる業務の経験3年以上
- 設備システムの構築経験 3年以上 (他業界でも可)
- オペレーション、メンテナンス、開発に関するグローバルおよびローカル手順に習熟していること
- OQ, PQ, DQ,IQ,PVなどの文書作成経験をお持ちであること
- コミュニケーションスキルは必須。
- オートメーション(CSV)内のC&Qのスキル
- 流暢レベルの日本語力、 ビジネスレベルの英語力をお持ちであること。
- 学歴不問
- 年数回の海外出張あり
- 化学または製薬業界でのオートメーションにおけるエンジニアリング経験が望ましい。
Skills Desired
Automation, Automation Testing, Control Engineering, Control Systems, Engineering, Hmi (Human-Machine Interface), Laboratory Equipment, Plc (Programmable Logic Controller), Problem Solving Skills, Robotic Process Automation (Rpa), Robotics, Software Testing, Test Automation, Test Cases, Test Engineer-
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