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  • 2 weeks ago

jobs description

This is an exciting opportunity for a Senior Process Validation Engineer to provide validation leadership on technical projects and ensure the timely execution of supplier validations within a Vascular Research & Development team.

Responsibilities:

Plan, lead, challenge and execute on process validations across various elements of the process (including Supplier Validations) within the agreed project timeframe.
Have a strong knowledge of process validations and related activity such as MVP, Risk Assessments (pFMEA), TMV, IQ/OQ/PQ-PPQ and MVR.
Understand how to establish documented evidence of the above activities and be able to review and critically challenge such documentation.
Ensure that production equipment is correctly installed, operates within set calibration tolerances and performs safely.
Have a strong working knowledge of regulatory compliance standards and procedures (e.g. ISO13485, FDA, EU MDR, etc).
Present and contribute at Technical and Phase reviews ensuring all... required data and deliverables are present, complete, and robust.
Provide input, updates and direction to management and other key stakeholders on various technical and regulatory issues.
Provides mentoring and guidance to other functional areas and junior engineers in applying validation principles
Limerick Ireland

salary-criteria

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