Commissioning & Qualification Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Sunto, Shizuoka, Japan

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

主な職務及び主な責任 Major Job Duties and Responsibilities:

・製造設備およびシステムの変更ならびに新製品導入(NPI)に伴う、コミッショニングおよび適格性評価(C&Q)プロセスを担当し、品質およびコンプライアンスを確保する。

Responsible for commissioning and qualification (C&Q) activities associated with equipment changes and new product introductions (NPI), ensuring quality and compliance of manufacturing equipment and systems.

・プロトコルの作成、検証の実施、データ分析、逸脱調査、C&Q関連文書および報告書の作成、ならびにC&Qプロセス中に発生する技術的課題の解決を主導する。

Develop protocols, execute qualification activities, analyze data, investigate deviations, prepare C&Q documentation and reports, and lead the resolution of technical issues arising during C&Q activities.

・製造、品質保証及びその他関連部門と連携し、設備およびシステムに関するC&Q活動を円滑に推進する。

Collaborate with Manufacturing, Quality Assurance, and other relevant functions to effectively execute C&Q activities for manufacturing equipment and systems.

・生産設備およびシステムに関する技術的課題、設備トラブルおよび品質問題のトラブルシューティングを実施し、原因調査、影響評価および問題解決を主導または支援する。

Conduct troubleshooting of technical issues, equipment failures, and quality-related problems associated with manufacturing equipment and systems, leading or supporting root cause investigations, impact assessments, and resolution activities.

・製造エリアにおける業者の施工管理および安全管理を実施する。

Supervise vendor activities and construction work in manufacturing areas to ensure compliance with site requirements and safety standards.

・EHS方針、基準、手順を遵守し、設備およびシステムに関する安全要求事項の実装ならびに継続的な改善を推進する。

Ensure compliance with EHS policies, standards and procedures, and drive the implementation and continuous improvement of safety requirements for manufacturing equipment and systems.

法規制の順守に関する責任 Regulatory Compliance Responsibilities:

• GMP/GCTP、全ての会社/サイトのポリシー/手順及び法令を遵守すること。

Project execution engineer must follow GMP/GCTP, all company/site policies/procedure and regulations.

教育/経験Education and Experiences:

• 新製品導入（NPI）に伴う設備・システム対応、または生産設備・システムの新規導入、変更、立上げ、検証に関する実務経験を有すること。コミッショニング、適格性評価、バリデーションまたは同等の業務経験を有することが望ましい。

Experience in equipment and system activities associated with new product introductions (NPI), or in the implementation, modification, start-up, and testing of manufacturing equipment and systems. Experience in commissioning, qualification, validation, or equivalent activities is desirable.

• 生産における機械技術または制御技術またはOT技術の知識及び経験

Experience in mechanical or control or OT technologies in production.

• 製薬・化粧品・食品企業での就業経験を有していることが望ましい。

Experience of working in the pharmaceutical or cosmetic or food industries is desirable.

• 大学卒以上もしくは同等の知識・経験を有すること。工学系バックグラウンドが望ましい。

University/Bachelor’s Degree or equivalent knowledge and experience. Engineering background is desirable.

知識、資格、及び技能 Knowledge, Qualification and Skills:

• 最小限の監督の下で独立して業務を遂行できる能力

Able to work independently with minimal supervision

• 優先順位を理解し、整理する能力

Understanding priority and organized

• チャレンジを受け入れる能力

Accept challenges

• 聞く力と理解力

Having the ability of listen and understanding

• 他部署との良好な協働およびコミュニケーションスキル

Good collaboration and communication skills with other departments

• リスク分析及び問題解決能力

Risk analysis and problem-solving skills

• 議事録や技術文書作成能力

Documentation skills for technical report and meeting minutes

• ビジネスレベルの英語力を有していることが望ましい。

Business-level English proficiency is desirable

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Required Skills:

Preferred Skills:

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy