Senior CQV Engineer ã·ãã¢CQVã¨ã³ã¸ãã¢
Senior CQV Engineer ã·ãã¢CQVã¨ã³ã¸ãã¢
Posted on :
22-08-2025
Employer Active
1 Vacancy
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Job Description
CQV
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CAI//(CQV)
CAI1996100%800FDA
Are You Ready
CAI
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CAI
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CQV
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WFIROHVACFAT/SATURSP&IDIQ/OQ/PQ
ISPE Baseline Guide 52
- cGMP PIC/s GMP EU GMP
-CQV
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-CQV/
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-Microsoft WordExcel
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8:00-17:00
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CAI is looking for an individual with arangeof experiencein the areas of commissioning qualification and validation to join ourteam in in the pharmaceutical medical deviceor biotechnologyindustries is required.
Company Description:
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
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 Companys 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:
8:00-17:00
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)
Vacations:
Completely 2 days off per week
National holidays
Annual paid vacations
Annual paid sick leave
#LI-JD1
- a year
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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