Business Services & Consulting • all cities, NE 30
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.
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.
Our approach is simple; we put the client's 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 person's success is everyone's 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.
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 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.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.
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.
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.
Our approach is simple; we put the client's 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 person's success is everyone's 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.
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 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.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.
