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Senior CQV Project Manager ã·ãã¢ããªãã¼ã·ã§ã³ããã¸ã§ã¯ãããã¼ã¸ã£ã¼
Posted on :
22-08-2025
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1 Vacancy
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Job Description
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CAI//(CQV)
CAI1996100%800FDA
Are You Ready
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Senior CQV Project Manager
Yamagata / Japan / Full-time
The CAI Japan team is looking for individuals with a variety of experience in the field of commissioning qualification and validation (CQV) of production facilities and equipment in the pharmaceutical/medical device/biotechnology industry.
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 Ongoing education (internal and external)
l Opportunity to work on cutting-edge projects in a rapidly developing field
Business Description:
Senior CQV Project Manager
1. Lead a project team on site to execute Commissioning qualification and validation (CQV) documentation of pharmaceutical or medical device production facilities utilities and equipment and deliver success results.
2. Create CQV protocols perform work at customer sites and prepare summary reports
CQV
3. Plan/coordinate work in documentation and execution manage execution cycles and provide direction to small teams.
Required Experiences and requirements:
1. Project management experience at a production facility of a pharmaceutical company producing oral solid dosage forms (e.g. tablets or powders not biopharmaceuticals)
2. Experience (15 years) performing commissioning qualification and validation in FDA-regulated industries such as pharmaceuticals and medical devices
*Facility and equipment start-up walk-down & troubleshooting utilities (WFI RO HVAC) building automation or other pharmaceutical manufacturing processes or equipment FAT/SAT URS design review P&ID IQ/OQ/PQ. Experience in creating & executing protocols at global working environment.
3. Direct the accomplishment of the scope of work as defined within a proposal or contract.
4. Identify requested work that falls outside of the current proposal/ contract and initiates a scope change Project Management prior to performing any out-of-scope work.
5. Responsible for project safety
6. Submitting monthly status reports to the customer and others
7. Managing deliverables Deliverables Management
8. Knowledge of cGMP PIC/s GMP EU GMP
9. Knowledge of technical issues that may arise in CQV projects
10. Excellent technical problem solving and troubleshooting skills
11. Initiative to multi-task and accurately complete assigned tasks by established deadlines
12. Experience in planning/directing CQV activities
13. Familiarity or equivalent experience with manufacturing processes such as biotechnology aseptic manipulation methods aseptic fill and finish solid dosage forms and gene therapy.
Required Skills:
1. Bachelors or Masters degree in a related scientific or engineering field or equivalent work experience
2. Ability to work independently while quickly building and training project teams
3. High attention to detail
4. Microsoft Word and Excel
5. Business level both English and Japanese proficiency
6. Ability to travel as needed
7. Nationality: preferably Japanese but a non-Japanese citizen with working permit in Japan is also appreciated.
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:
Yamagata Prefecture
(There is a possibility of working nationwide after the project ends. Details will be explained at the interview)
Vacations:
Completely 2 days off per week
National holidays
Annual paid vacations
Annual paid sick leave
#LI-JD1
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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