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Sr Validation Subject Matter Expert ・ Computer Systems Validati…
| Hiring Company | 武田薬品工業株式会社 |
| Location | Osaka Prefecture |
| Job Type | Permanent Full-time |
| Salary | 5.5 million yen ~ 11 million yen |
Job Description
【求人No NJB2207746】
Acting as Computer Systems Validation （CSV） engineer in the Engineering workstream of the project he/she will:
■Report to the CQV Lead/Validation Manager.
■Develop and execute validation plans protocols and reports for computer systems.
■Ensure that computer systems are compliant with regulatory requirements including FDA regulations GxP guidelines and industry standards.
■Collaborate with cross functional teams to identify and mitigate risks associated with computer systems.
■Conduct risk assessments and develop risk mitigation strategies for computer systems.
■Develop and maintain standard operating procedures （SOPs） for computer system validation.
■Provide training and guidance to end users on the proper use of computer systems.
■Participate in audits and inspections to ensure compliance with regulatory requirements.
■Keep up to date with industry trends and best practices related to computer system validation.
■Manage vendors/contractors related to CSV activities.
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Daily Conversation |
| Minimum Japanese Level | Native |
| Minimum Education Level | Technical/Vocational College |
| Visa Status | Permission to work in Japan required |
Required Skills
■BA or BS degree preferably in the engineering or science field. ■5+ years of validation experience・for non mgr role. ■Experience in validation of GMP manufacturing process control systems （e.g. Allen Bradley PLC Delta V BAS Siemens） ■Experience in control systems validation as part of a large capital project （e.g. new facility installation） is a plus. ■Experience in Plasma manufacturing is a plus. ■Prior experience in use of KNEAT （paperless validation system） in a validation project is a plus. ■Prior experience interacting with the FDA and other regulatory agencies. ■Excellent verbal and written communication skills in English and Japanese.Job Location
- Osaka Prefecture
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 5.5 million yen ~ 11 million yen |
| Work Hours | 08:00 ～ 16:45 |
| Holidays | 【有給休暇】初年度 12日 1か月目から 完全週休二日制（土・日）、祝日、メーデー、年末年始、他 特別有給休暇、リフレッシュ休… |
| Industry | Pharmaceutical |
Job Category
- Electronics and Semiconductor Technology > Production Engineering (Electronics and Semiconductor Technology)
- Electronics and Semiconductor Technology > Design, Development Engineer
