Validation Engineer - Sligo

Company: Confidential
Your Application: You have not applied yet
Location: Sligo, Irlanda


The role of Validation Engineer will be responsible for coordinating all validation & verification activity of new products introduced to the site, as well as changes to existing products, equipment and processes.
The Job:

Co-ordinate all validation activity within the company working directly with the Engineering & Operations Departments.
Drive successful validation / verification of processes, systems, software and equipment installations and revalidations within the cross functional team.
Maintain & publish the Master Validation Plan, highlighting challenges, and identifying solutions to ensure effective and on time execution.
Prepare and complete Validation Protocols and Reports in support of product & process changes, as well as the new product introduction effort.
Build the validation / verification packs for
retention on file, to include all supporting material from cross functional areas, e.g. Risk Assessments, Metrology, Process Engineering, and ensure same is always ready for sharing with customers & auditing bodies.
Coordinate & discuss validation activity with customers and in line with their requirements.
Monitor the progress of validation projects on a daily/weekly/monthly basis ensuring that there is continuous drive/focus on meeting schedules.
Required Qualifications:

Bachelor's degree in Quality/Assurance / Engineering
2 years? experience in a similar role in the Medical Device Industry.
Knowledge of ISO, MDD, FDA requirements essential.
Knowledge of Quality Standards, Validation Regulations and Guidance Documents required
For more on the role call Nigel on 087 3618142 or send your CV for consideration

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