Senior CQV Engineer シニアCQVエンジニア

Tokyo  /  Japan  /  Full Time

東京 / 日本 / 正社員(フルタイム)
CAI日本チームでは、製薬/医療機器/バイオテクノロジー業界において、生産設備や機器の試運転(コミッショニング)・適格性検査(クオリフィケーション)・バリデーション(CQV) の分野で様々な経験を積んだ方を募集します。
-   競争力のある給与
-   継続的な教育(社内外)
-   発展著しい分野で最先端のプロジェクトに携わる機会
- 誠実に行動する
- 互いに奉仕する
-  社会に奉仕する
-  未来のために働く
-  医薬品または医療機器の生産施設、ユーティリティ、機器の試運転(コミッショニング)、クオリフィケーション(適格性確認)、バリデーション(CQV) 文書の作成
- CQVプロトコルの作成、顧客サイトでの作業実施およびサマリーレポートの作成
- ドキュメントの作成や実行における作業の計画/調整、実行サイクルの管理、小規模チームへの指示
- 関連する科学または工学分野の学士号または修士号、または同等の実務経験
- 医薬品・医療機器などのFDA規制産業における試運転(コミッショニング)や適格性検査(クオリフィケーション)、バリデーションの実施経験(5~12年)
※ISPE Baseline Guide 5(第2版)に精通しておられる方を歓迎します。
-  cGMP, PIC/s GMP, EU GMPに関する知識
- CQVプロジェクトで起こりうる技術的問題に関する知識
-  優れた技術的問題解決能力とトラブルシューティング能力
-  細部への高い注意力
-  マルチタスクをこなし、定められた期限までに担当業務を正確に遂行する主体性
-  プロジェクトチームを迅速に構築・育成しながら、自立して業務を遂行できる能力
- CQV活動の計画/指示経験
-  バイオテクノロジー、無菌操作法、無菌フィル&フィニッシュ、固形製剤、遺伝子治療などの製造プロセスに精通している、または同等の経験がある方
- Microsoft WordおよびExcel
- 語学力:日本語および英語(ビジネスレベル) 
- 必要に応じて出張可能な方
給与 年収800万円〜1,000万円
CAI is looking for an individual with a range of experience in the areas of commissioning, qualification, and validation to join our team in Japan. Experience in the pharmaceutical, medical device or biotechnology industries is required.
Company Description:
Founded in 1996, CAI is one of the leading GxP/engineering consulting firms in the United States. Today, CAI has more than 850 employees worldwide and operates in 13 countries. CAI has strong connections with pharmaceutical industry associations such as ISPE and PDA. We provide commissioning, qualification, validation, start-up, project management, and GxP consulting services for production facilities and equipment to the life science industry, including pharmaceuticals and medical devices, as well as data centers and other industries that require strict regulatory compliance.
In recent years, CAI has experienced remarkable growth in Asia and has established a Japanese subsidiary in 2023. We are looking for engineers who are looking for a global career in order to provide our services, which we have been providing to major international life science companies, mainly in Europe and the United States, to Japanese life science companies.
CAI offers a wide range of benefits in return for the skills and knowledge its employees possess.
l  Competitive Salary
l  Continuing education (internal and external)
l  Opportunities to work on cutting edge projects in a highly evolving field
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
At CAI, we are committed to living our Foundational Principles, both professionally and personally:
l  We act with integrity
l  We serve each other
l  We serve society
l  We work for our future.
Position Description:
Senior CQV Engineer
- Commissioning, qualification, and validation (CQV) documentation of pharmaceutical or medical device production facilities, utilities, and equipment
-  Create CQV protocols, perform work at customer sites and prepare summary reports
-  Plan/coordinate work in documentation and execution, manage execution cycles and provide direction to small teams
Required Skills and Experience:
- BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
- 5 – 12 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
- Familiarity with Baseline Guide 5 (Second Edition) a plus- Knowledge of technical issues that may arise in CQV projects
- Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
- High attention to detail
- Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
- Ability to work independently, while quickly building and nurturing a project team
- Experience in planning / directing C&Q activities
- Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
- Microsoft Word and Excel proficiency
- Business level both English and  Japanese proficiency
- Ability to travel if required
Salary and Benefits:
Salary will be determined in accordance with the Company's regulations after due consideration of experience, ability, and other factors. 
Salary evaluation once a year
Full social insurance
Project Travel expenses fully paid 
Employment status:
Full-time employee 
Working hours:
Work Location:
Nationwide, with a focus on the Tokyo metropolitan area or Kansai area, depending on the project for which you are responsible.
*Remote work is possible (depending on the project you are in charge of) 
Completely 2 days off per week
National holidays
Annual paid vacations
Annual paid sick leave



(Varies by Country, Below is a General Overview)

  • Comprehensive Health Insurance coverage aligned with local region regulations
  • Paid Time Off
  • ESOP/401K – 15% Company Contribution (US Only)
  • 15% Company Pension Contribution (Europe and APAC Regions)
  • Company Paid Life Assurance
  • Company Paid Income Protection/Long-Term Disability
  • Career/Professional Development Opportunities
  • Additional benefits/leave entitlements based on local regional requirements.
  • Other Benefits Depending on Country