Job Description

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:

Founded in 1996, CAI is one of the leading GxP/engineering consulting firms in the United States. Today, CAI has more than 850 employees worldwide and operates in 13 countries. CAI has strong connections with pharmaceutical industry associations such as ISPE and PDA. We provide commissioning, qualification, validation, start-up, project management, and GxP consulting services for production facilities and equipment to the life science industry, including pharmaceuticals and medical devices, as well as data centers and other industries that require strict regulatory compliance.

In recent years, CAI has experienced remarkable growth in Asia and has established a Japanese subsidiary in 2023. We are looking for engineers who are looking for a global career in order to provide our services, which we have been providing to major international life science companies, mainly in Europe and the United States, to Japanese life science companies.

CAI offers a wide range of benefits in return for the skills and knowledge its employees possess.

• Competitive salary
• Ongoing education (internal and external)
• Opportunity to work on cutting-edge projects in a rapidly developing field

Meeting a Higher Standard

CAI puts the client's interests first, continues to act until the right results are achieved, and takes all necessary measures to achieve those results. As professionals and as individuals, our employees practice the following basic principles:

• Act with integrity
• We serve one another
• Serving Society
• Working for the Future

Business Description:

Senior CQV Project Manager

• 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.
• Create CQV protocols, perform work at customer sites and prepare summary reports
• P lan/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.

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. Bachelor's or Master's 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 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:

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.