募集要項
- 募集背景
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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.
- 仕事内容
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We are now seeking a Senior CQV Engineer to join our growing operations in Japan.Position Description:
We are now seeking a Senior CQV Engineer to join our growing operations in Japan. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. He/She is responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
The role of a Senior CQV Engineer is to:
Independently develop documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
- 応募資格
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- 必須
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5 – 12 years’ experience performing commissioning and/or qualification activities in an FDA regulated industry.
Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
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.
- 歓迎
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BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
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.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
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.
- 雇用形態
- 正社員
- 勤務地
- 千葉県
- 年収・給与
- 1000万円 ～ 1199万円
