Senior Validation Engineer

2 weeks ago


Malden, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time
Job Summary

We are seeking a highly skilled Senior Validation Engineer to join our IT Quality Assurance team at Katalyst Healthcares and Life Sciences. As a key member of our team, you will be responsible for ensuring the quality and integrity of our computer systems and data.

Key Responsibilities
  • Computer System Validation: Ensure that our computer systems meet the required standards for data integrity, including 21 CFR Part 11, 210, 211, 312, 314, 820 GXP, GMP, GDP, GLP, and CAPA.
  • Change Control and Risk Assessment: Develop and implement change control procedures to minimize risks and ensure data integrity.
  • Database Management and Trail Master File: Design and implement databases to store and manage data, and ensure that trail master files are accurate and up-to-date.
  • System Validation and Testing: Validate and test computer systems to ensure they meet the required standards.
Requirements
  • Technical Skills: Proficiency in HL7, HIPAA, SOP, SQL, HTML, XML, EDI, Silk, Client Quality Center, Jira Confluence, and Microsoft TFSLIMS.
  • Education and Experience: Bachelor's degree in Computer Science, Engineering, or a related field, and at least 5 years of experience in computer system validation and quality assurance.


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