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Technical Validation Manager
1 week ago
The ICDS Group seeks a skilled Technical Validation Manager to oversee and manage the validation lifecycle for our manufacturing processes. As a Senior Validation Specialist, you will be responsible for leading the design transfer process and ensuring the technical aspects of the validation lifecycle are executed effectively.
Key Responsibilities:
- Lead the validation team in executing technical and equipment validation projects according to pre-determined protocols and production requirements.
- Develop and maintain comprehensive validation policy and procedures to ensure compliance with current regulatory requirements.
- Collaborate with Operations, Planning, and Engineering groups to ensure successful validation of all manufacturing processes.
- Manage the activities of a defined team of Validation Engineers, including day-to-day work allocation and prioritization of work.
Requirements:
- Bachelor's degree in a relevant technical field or equivalent experience.
- A minimum of 5 years' high-volume engineering experience in medical device manufacturing.
- A minimum of 3 years' validation experience and strong working knowledge of statistical techniques.
- Process development experience, risk analysis, FMEAs, and documentation skills.
About Us:
The ICDS Group is a dynamic company that values innovation and excellence in manufacturing.