Senior Validation Expert
1 week ago
About This Role:
This is an exciting opportunity to lead the validation lifecycle at a major site. As Senior Validation Engineer, you will oversee and manage all technical aspects of the validation process, ensuring compliance with current regulatory requirements.
Responsibilities:
- Lead Technical Teams: Manage and motivate cross-functional teams to execute validation projects efficiently and effectively.
- Validation Strategy: Develop and implement a robust validation strategy that meets the needs of all stakeholders, including regulatory bodies.
- Validation Policy and Procedures: Create and maintain comprehensive validation policies and procedures that ensure adherence to regulatory requirements.
- Team Management: Oversee the activities of a defined team of validation engineers, providing guidance and support as needed.
Requirements:
- Education: Bachelor's degree in a relevant technical field, such as engineering or science.
- Experience: Minimum 5 years of high-volume engineering experience in a medical device industry, with a minimum of 3 years of validation experience.
- Skillset: Strong working knowledge of statistical techniques, Minitab, Six Sigma (Green Belt), and sampling plans/sizes.
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