Senior Validation Engineer
As a key member of our validation team, you will oversee and manage the validation lifecycle at our site.
* Lead the transfer process and ensure technical aspects of validation are executed effectively.
* Drive continuous improvement initiatives to enhance processes and maintain high quality standards.
Responsibilities:
* Be a leader within the validation team for all technical and equipment validation projects.
* Ensure that plant and equipment have been validated in compliance with current regulatory requirements.
* Develop a strategy to satisfy regulatory bodies' requirements, including effective use of process development and DOE activities.
* Produce and maintain comprehensive validation policy and procedures.
* Ensure execution of allocated validations according to the plant Validation Master Plan.
Requirements:
* Bachelor's degree in a relevant technical field.
* A minimum of 5 years experience in engineering with focus on medical devices.
* A minimum of 3 years experience in validation.
* Strong working knowledge of statistical techniques, Minitab, Six Sigma, Sampling Plans/Sizes.