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- Participates in commissioning and qualification activities related to Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation, cleaning validation, SIP validation and shipping validation in accordance with Takeda’s internal procedures and industry standards.
- Participates in the creation of equipment lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
- Participates in investigation revolving around discrepancies identified during qualification activities, working in collaboration with cross-functional teams
- Involved in the coordination of the commissioning and qualification activities of validation lifecycle documents
- Coordinates and lead continuous improvement projects
- Executes validation maintenance activities, e.g. executes periodic reviews, coordinate periodic monitoring activities and perform periodic requalification
- Participates in validation meetings with cross functional teams in resolving validation issues.
- Any other duties as assigned by supervisor/designated person to ensure Continuous Improvement in the Site’s Engineering Services
- Keen interest to work in a biopharmaceutical industry
- Knowledge and experience using Microsoft 365 applications
- Detail-oriented and proactive towards job responsibilities
- Good interpersonal, communication, presentation, and analytical skills
- Ability to interact with multiple stakeholders
- Good team player
- Independent with good initiatives and learning attitude
- Participates in commissioning and qualification activities related to Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation, cleaning validation, SIP validation and shipping validation in accordance with Takeda’s internal procedures and industry standards.
- Participates in the creation of equipment lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
- Participates in investigation revolving around discrepancies identified during qualification activities, working in collaboration with cross-functional teams
- Involved in the coordination of the commissioning and qualification activities of validation lifecycle documents
- Coordinates and lead continuous improvement projects
- Executes validation maintenance activities, e.g. executes periodic reviews, coordinate periodic monitoring activities and perform periodic requalification
- Participates in validation meetings with cross functional teams in resolving validation issues.
- Any other duties as assigned by supervisor/designated person to ensure Continuous Improvement in the Site’s Engineering Services
- Keen interest to work in a biopharmaceutical industry
- Knowledge and experience using Microsoft 365 applications
- Detail-oriented and proactive towards job responsibilities
- Good interpersonal, communication, presentation, and analytical skills
- Ability to interact with multiple stakeholders
- Good team player
- Independent with good initiatives and learning attitude