Senior Validation Engineer
We are seeking a skilled Senior Validation Engineer to lead the validation and Advanced Product Quality Planning (APQP) lifecycle at our site in South Dublin.
About the Role
In this key position, you will be responsible for overseeing the design transfer process and ensuring the technical aspects of the validation lifecycle are executed effectively.
Key Responsibilities
* Lead the validation team for all technical and equipment validation projects in line with predetermined protocols and production requirements.
* Ensure that the design, installation, and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.
* Develop a strategy to ensure that the validation approach satisfies the requirements of all regulatory bodies; regulations, standards, guidance, and GMP, including effective and appropriate use of process development and DOE activities.
* Produce and maintain appropriate and comprehensive validation policy and procedures.
* Ensure execution of allocated validations according to the plant Validation Master Plan.
Requirements
* BSc/BEng or similar relevant technical degree.
* A minimum of 5 years high volume engineering experience in Medical Devices.
* A minimum of 3 years validation experience.
* Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), Sampling Plans/Sizes.
* Process development experience (DOE's etc) Risk Analysis/Risk Management, FMEA's, etc.
* Strong documentation skills.
* Process validation training and experience.
Estimated Salary:
$80,000 - $120,000 per annum, depending on experience.
Location:
South Dublin.