Sr Validation Subject Matter Expert – Computer Systems Validation, Japan New Plasma Facility Project
- 採用企業名
- 武田薬品工業株式会社
- 職種
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技術系(機械設計・製造技術) - 製造技術・生産技術(電気・PLC制御)
技術系(機械設計・製造技術) - プラントエンジニア(電気)
- 雇用形態
- 無期雇用
- 勤務地
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大阪府
- 仕事内容
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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.
- 求める経験
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■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.■職種未経験者:不可
- 年収
- 550万円 - 1100万円
- 語学力
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英語力:初級以上