CSV Specialist in Healthcare Technology

1 week ago


Austin, Texas, United States Katalyst HealthCares & Life Sciences Full time
Job Overview:

We are seeking a dedicated CSV Engineer to join our team at Katalyst HealthCares & Life Sciences. This role is pivotal in ensuring the integrity and compliance of our data systems.

Key Responsibilities:
  • Industry Experience: Engage in projects within the medical device and pharmaceutical sectors.
  • Validation Expertise: Conduct thorough Computer Systems Validation to ensure systems meet regulatory standards.
  • System Validation: Validate Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, custom applications, and Commercial Off-The-Shelf (COTS) software.
  • Regulatory Knowledge: Familiarity with ISO standards, FDA regulations, CAPA processes, non-conformance management, and change control procedures.
  • Risk Assessment: Perform comprehensive software risk assessments to identify and mitigate potential issues.
  • Collaboration: Work effectively in both team settings and independently in a dynamic environment.
  • Software Testing: Execute detailed testing and validation of Critical Category (CAT) software for process control and monitoring.
  • Utility Systems Validation: Ensure validation of Non-Critical Category (CAT) software for utilities and ancillary systems.


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