Summary
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。
About the Role
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。
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
