[Innovative Medicine] 生産物流本部 富士工場 エンジニアリング部 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