Validation Process Manager

3 days ago


Limerick, Limerick, Ireland HERO Recruitment Full time
Job Overview

We are seeking a highly skilled professional to lead our validation efforts.

In this role, you will be responsible for developing and executing Test Method Validations to ensure compliance with quality and regulatory standards.

Responsibilities:

  • TMV Development: Develop and execute TMVs for test equipment, ensuring compliance with QMS and regulatory standards.
  • Process Validation: Validate and implement medical device manufacturing processes, ensuring efficiency and regulatory adherence.
  • Qualification Requirements: Identify and establish IQ, OQ, and PQ requirements.
  • Data Integrity: Define acceptance criteria, analyze process outputs, and ensure data integrity.
  • Documentation: Prepare and maintain validation protocols, reports, and supporting documentation per regulatory and quality requirements.
  • Verification Testing: Conduct and oversee verification testing to ensure compliance and reliability.
  • Project Management: Lead and execute validation projects, ensuring timely delivery while coordinating across functions.
  • Collaboration: Work closely with Quality, R&D, and Manufacturing teams to align validation activities with business needs.
  • Leadership: Act as a delegate for the Manufacturing Engineering Manager and Senior Test Engineer, while supporting junior engineers.
  • Continuous Improvement: Identify and drive process enhancements to improve efficiency, compliance, and product reliability.


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