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.