Collins McNicholas Limerick Ireland
3 weeks ago
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.
• 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.
• Technical Degree (or greater) in Engineering/Science preferred.
• 5+ years of process validation experience ideally in the Medical Device industry.
• 3+ years of experience leading process validation activities.
• Demonstrated ability to successfully complete a range of process validation activity (e.g. IQ/OQ/PQ, Risk Assessment, TMV and MVP/MVR).
• Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
• Ability to manage the overall process validation project (including change management where applicable).
• Experience of extrusion and/or balloon forming processes is a distinct advantage.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Senior Process Validation Engineer Limerick jobs
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