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

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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-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-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-relat...