Senior Validation Engineer
14 days ago
I am currently recruiting for an excellent Process Validation Engineer with a well known medical device company in Limerick. This is initially a 12 month contract role with scope to be extended beyond this.
The primary purpose of this position is to provide validation leadership on technical projects and ensure timely execution of supplier validations within the Vascular Research & Development team. The successful candidate will be responsible for establishing and ensuring adherence to standardized validation best practices, whilst ensuring that company and external regulatory, quality, and compliance requirements are met.
- 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.
- Ensure that the holistic process (including testing) is robust and compliant to the requirements of multiple regulatory bodies.
- Have a strong working knowledge of regulatory compliance standards and procedures (e.g. ISO13485, FDA, EU MDR etc).
- Review DOE and/or other engineering trial data, be able to challenge the findings and present on conclusions.
- Liaise and work effectively with core team members in other functional areas and with critical partners (internal and external) ensuring expectations and deliverables are clearly understood.
- Generate and maintain required documentation in line with the Quality Management System and associated regulatory requirements.
- 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.
- Host regular meetings with the main suppliers and challenge their decision-making and documentation as appropriate.
- 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).