Validation Process Engineer

1 week ago

Limerick, Limerick, Ireland beBee Careers Full time
Test Method Validation Specialist

We are seeking a highly driven individual to join our medical device manufacturing team on a 12-month contractual basis.

Key Responsibilities:
  • Design, plan, and execute validations of test methodologies used in production and quality assurance, ensuring alignment with regulatory frameworks and company procedures.
  • Lead process validation efforts for medical device manufacturing operations, driving compliance and quality.
  • Determine the necessary criteria and documentation for installing new testing fixtures and production tools.
  • Conduct thorough analysis of processes, defining key performance parameters and acceptable output criteria.
  • Compile comprehensive validation protocols and reports that adhere to industry and organizational requirements.
  • Perform verification testing to confirm process consistency and reliability.
  • Contribute to cross-functional project planning and ensure timely execution of validation activities.
  • Maintain meticulous documentation and data records, ensuring audit-readiness.
  • Apply critical thinking to identify and resolve technical issues effectively.
  • Work independently across multiple ongoing tasks, demonstrating flexibility and self-direction.
  • Actively pursue opportunities for professional growth and continuous improvement.
  • Support or represent senior engineering leadership in their absence, including the Test Engineering and Manufacturing Management functions.
Candidate Profile:
  • A degree in Engineering or a related scientific/technical field is preferred, though equivalent practical experience will be considered.
  • At least five years of hands-on experience in validation within a regulated industry, ideally medical devices.
  • Strong ability to manage projects and meet deadlines in a high-pressure environment.
  • Excellent communication and collaboration skills, with the capacity to engage effectively across teams and management levels.
  • Strong organizational capabilities and attention to detail.
  • Proven aptitude for troubleshooting and process improvement.
  • Enthusiastic team player with a proactive mindset and a passion for delivering quality results.
  • Committed to personal development and maintaining all required job-related certifications or training.

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