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Validation Specialist
| Company | Kao Corporation |
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| Location | Cincinnati, OH, USA |
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| Salary | $65000 – $85000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor of Science degree, in engineering, science or relevant technical area.
- 5+ years of experience in regulatory industry with validation profile.
- Knowledge of FDA compliance regulations applicable to Equipment, Process, and Cleaning Validation.
- Experience in OTC manufacturing or testing.
- Knowledge of FDA qualification and validation guidelines for equipment.
- Understanding and adherence of Good Documentation Practices and current Good Manufacturing Practices.
- Knowledge of computer systems and software such as SAP (PLM, QM), Empower/Chromeleon, and Microsoft Office.
Responsibilities
- Execution of Validation/revalidation activities and related documentation – Scheduling, Planning and review of validation activities.
- Authoring of Documentation: including but not limited to validation plans and reports, requirements and design specifications, risk assessments, test plans and summary reports.
- Manage all facets of assigned validation projects while maintaining communication with inter departments on project status and assistance needed.
- Write and revise SOPs, WIs, and Methods for calibration, maintenance (planned and unplanned), qualification, and validation of equipment.
- Support Quality Management (QM), Plant Services, and Quality Services (QS) in design, manufacture, evaluation, and calibration of measurement standards and test systems to ensure selection of equipment that meets requirements.
- Supports the coordination and management of routine calibration and maintenance (planned and unplanned) of equipment.
Preferred Qualifications
No preferred qualifications provided.
