Senior Validation Engineer
Our client is a global leader within the medical device manufacturing and are based in County Wexford. They specialise in the manufacture of medical device products, with their company being their centre of excellence for the production of these products. The company employees over 800 people at its facility and this number continues to grow! A new role has opened up for a Senior Validation Engineer to join their Design Assurance team.
About the job:
The Senior Validation Engineer will be responsible for developing, maintaining and improving relevant validated test methods for all newly designed and newly introduced products that are agreed with the R&D and Engineering NPI teams. The role will also focus on reviewing current test protocols and checking compliance in relation to current test protocols .
The role will also be responsible for developing, maintaining and improving a standardised validation process for the Plant to ensure compliance to required regulations.
- Ensure continued compliance with IOS 13485 and FDA Regulatory Standards.
- Drive the site validation function in the development and provisions of documentation for the qualification (IQ/OQ/PQ/PPQ) related to agreed Plant validations.
- Working as a member of the plant project team to review what projects require validation.
- Assist with URS development for software validation projects.
- Interact with other departments conducting the validations before protocols are written and again to review the validation data for the validation report.
- Ensure that all data, results and information associated with qualification and validation data provided for reports are in accordance with written procedures.
- Implement, deploy and revise as applicable all Validation procedures
What you'll bring:
As the ideal candidate, you'll have a Degree in Engineering/Science alongside knowledge of Test Method Validation, and experience in design assurance duties and implementing relevant validated tests methods. You'll be interacting with different teams in the organisation, so good communication skills are essential.
This is an excellent opportunity for a Validation Engineer to work with a global leader in the medical device industry.
Your next step: Apply now!
No CV ready? Not sure yet? Feel free to contact me for more details. Call Leo Cordingley Phone: 086 049 5443 or connect with me on LinkedIn: https://www.linkedin.com/in/lcordingley/