Project Manager - CQV - Japan
Osaka,Japan
05-11-2024
Job Type
Permanent
Emp Type
Full Time
Industry
Construction and Engineering
Functional Expertise
Any
Salary Type
Annual
Salary
Negotiable
Job Description
Project Manager – Japan – Permanent Role
Position Requirements:
- 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.
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
- 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
- Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
- Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
- 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.
- Familiarity with Baseline Guide 5 (Second Edition) a plus
Other Requirements:
- • Expertise in Microsoft Word and Excel
- • Fluency in Japanese and English
- • Able to travel domestically if required