Validation Engineer -Longford
Our client, a Plastics & Medical Device Manufacturer based in Longford are looking for an experienced Validation Engineer to join their Quality team. The role is ideal for candidates with a background in Medical Device Manufacturing, Validation, CAPAs and experience working in a high volume GMP Environment.
What's on offer:
* A competitive salary-up to 65k DOE
* Pension Scheme
* Health Insurance
* Bonus structure
The Ideal Candidate:
* Do you have 2+ years' experience in Validation Engineering?
* Do you have experience working in New Product Development?
* Track record of working in a highly regulated Medical Device Manufacturing environment is essential.
* Knowledge and experience working to ISO Standards is required.
* Knowledge of Lean Six Sigma, Root Cause Analysis and CAPAs is essential.
The role:
* Write and monitor Quality & Validation protocol and standards.
* Develop and implement solutions to maintain and improve the QMS.
* Support compliance to ISO 13485 and ISO 14001 systems standards.
* Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
* Generation of risk assessments, covering cleaning, validation, and process.
* Review and execute of Factory Acceptance Testing and Site Acceptance Testing protocols.
* Directly support GMP and regulatory audits.
* Perform data analysis
* Support continuous improvement through Lean Six Sigma methodologies.
* Execution / development of change controls.
If you are an experienced Validation Engineer with a background in Medical Device Manufacturing, we would love to hear from you. Please send your CV to me directly at belinda.neary@manpower.ie.
#J-18808-Ljbffr