Validation Engineer

4 weeks ago


Sunnyvale, California, United States Katalyst Healthcares and Life Sciences Full time
{"title": "Test Method Validation Engineer", "content": "Job Summary

We are seeking a highly skilled Test Method Validation Engineer to join our team at Katalyst Healthcares and Life Sciences. As a key member of our quality assurance team, you will be responsible for ensuring the accuracy and reliability of our test methods.

Key Responsibilities
  • Test Method Validation: Conduct thorough validation of test methods to ensure adherence to quality standards.
  • Protocol Design: Design and implement protocols for validation processes, ensuring effective and efficient execution.
  • Documentation Management: Manage and navigate documentation effectively, ensuring seamless collaboration with the development team.
  • Test Fixture Qualification: Qualify test fixtures using Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Statistical Analysis: Apply statistical knowledge to select appropriate samples and run small characterizations.
  • Collaboration: Work closely with the development team to optimize processes and ensure successful validation.
Requirements
  • Experience: 7+ years of experience in a related field, with broad knowledge across multiple disciplines.
  • Statistical Skills: Strong statistical skills, including proficiency in standard gauge R&R.
  • Documentation and Protocol Design: Excellent documentation and protocol design skills.
  • Test Fixture Qualification: Proficiency in test fixture qualification IQ, OQ, PQ.
", "lang_code": "en-US"}
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