転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です
| 部署・役職名 | Senior Engineer （Commissioning, Qualifications and Validation） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Description About the job Our client 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. |
| 応募資格 |
【必須（MUST）】 Position Requirements• 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. • Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. • 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 • Managing the C＆Q documentation and execution lifecycle from SLIA generation through to OQ completion. • Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns • 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. • Familiarity with Baseline Guide 5 （Second Edition） a plus 【歓迎（WANT）】 Other Requirements• Expertise in Microsoft Word and Excel • Excellent oral and written English are required. • Able to travel if required |
| リモートワーク | 不可 |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/07/11 |
| 求人番号 | 3537741 |
採用企業情報
- 企業名は会員のみ表示されます
- 会社規模501-5000人
この求人の取り扱い担当者
-
- ?
- ヘッドハンターの氏名は会員のみ表示されます
会社名は会員のみ表示されます
-
- メーカー メディカル
-
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です