Cure Talent is delighted to partner with a global Medical Device manufacturing company dedicated to diabetes care. Due to their ongoing growth, we have an exciting opportunity for a Senior Validation Engineer to join their team in Dun Laoghaire.
As the new Senior Validation Engineer you will oversee a team creating, developing and providing support for validation strategies. You will create process validation and equipment qualification requirements and will review qualification and validation protocols.
To be successful in this role you will have proven Validation Engineering experience in a highly regulated environment, ideally Medical Devices with in-depth experience of creating and developing Validation Strategies.
Key Responsibilities:
* Oversee a team to create, develop and provide support for validation strategies.
* Manage process validation and equipment qualification requirements (IQ, OQ, PQ).
* Review qualification/validation protocols.
* Establish and maintain the status of the site validation system.
* Assist in change control documentation implementation and contribute to risk management reports.
Essential Skills, Knowledge & Experience:
* Proven experience of process and equipment validation
* Proven experience within a highly regulated manufacturing environment (Medical Devices, Pharma, Aerospace etc.)
* Proven knowledge and experience of Change Control and Risk Management processes.
* Engineering or Scientific Degree is highly advantageous.
* Knowledge and experience of ISO 13485 & ISO 14971 is highly advantageous.
If you're seeking an exciting opportunity to be part of a dynamic team driving medical technology innovation, don't miss out – get in touch today