Senior CQV Engineer シニアCQVエンジニア in Tokyo at CAI

CAI//(CQV)

CAI1996100%800FDA

Are You Ready?

CAI

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WFIROHVACFAT/SATURSP&IDIQ/OQ/PQ

ISPE Baseline Guide 52

- cGMP, PIC/s GMP, EU GMP

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8001,000

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8:00-17:00

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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.

CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

Are You Ready?

Our approach is simple; we put the clients interests first, we do not stop until it is right, and we will do whatever it takes to get there.

As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:

We act with integrity

We serve each other

We serve society

We work for our future

With employee ownership, one persons success is everyones success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.

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

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

- 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 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

Full-time employee

8:00-17:00

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

#LI-JD1