Validation Engineer for Computer Systems

2 weeks ago


Houston, Texas, United States Katalyst Healthcares and Life Sciences Full time
Position Overview:

Katalyst Healthcares and Life Sciences is looking for a skilled Computer System Validation Engineer to contribute to our projects. The successful candidate will be responsible for ensuring that our electronic systems comply with industry regulations and internal quality standards.

Key Responsibilities:
  • Validate the Electronic Document Management System (EDMS) to meet regulatory and quality benchmarks.
  • Develop and implement validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Ensure adherence to all relevant regulatory standards, particularly 21 CFR Part 11.
  • Collaborate with various departments such as Quality Assurance, Information Technology, and system users to collect requirements and facilitate comprehensive validation.
  • Document all validation processes and generate summary reports to reflect validation outcomes.
  • Identify and resolve validation-related issues to ensure optimal system functionality.
  • Provide necessary training and support to end-users regarding validated systems.
Qualifications:
  • Experience with Meridian EDMS or similar systems is preferred.
  • A Bachelor’s degree in Computer Science, Engineering, or a related discipline.
  • A minimum of 3 years of experience in computer system validation within the pharmaceutical or biotechnology sectors.
  • In-depth understanding of regulatory requirements including FDA, GxP, and 21 CFR Part 11.
  • Strong communication and documentation capabilities.


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