System Validation Expert

6 days ago

Chula Vista, California, United States Katalyst Healthcares and Life Sciences Full time
About the Role

Katalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist to join our team. As a CSV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' systems and processes.

Key Responsibilities
  • Project Management: Collaborate with project managers and client personnel to understand project objectives and develop comprehensive project plans.
  • Validation Planning: Author validation plans, user requirements documents, and system requirements documents to ensure compliance with regulatory requirements.
  • Testing and Quality Assurance: Develop and execute testing plans and scripts, prepare test summary reports, and finalize validation reports to ensure system quality and compliance.
  • Electronic Record Management: Manage and maintain electronic records in client document management systems to demonstrate compliance with government regulations.
  • System Integration: Support maintenance and enhancements for client custom integrations between Veeva QualityDocs and Cornerstone.
  • Consultation and Collaboration: Consult with client personnel to ensure validation activities and deliverables meet client corporate policies and procedures.
Requirements
  • Education: Degree from an accredited, four-year college or university; advanced degrees and certifications/certifications are highly desirable.
  • Experience: At least 5 years of relevant work experience in a computer system validation (CSV) role in the biotech/pharmaceuticals industry; knowledge of applicable regulations and guidance is highly desirable.
  • Technical Skills: At least 3 years of relevant work experience with Cornerstone On Demand; bonus points for experience in Compliance Wire, Veeva Quality Docs, SQL, and Python.
  • Project Management and Validation Methodology: Grounded in solid project management and system validation methodology, with the ability to set and manage expectations extremely well.
  • Quality Results: Proven track record of delivering quality results while handling multiple projects and competing priorities.
  • Risk Management: Thorough understanding of a Risk Management-Based Approach to system validations, including system risk categories and system class (GAMP 5).
  • Regulatory Knowledge: Working knowledge of 21 CFR Part 11 and Annex 11, as well as understanding of regulations around personal and patient data privacy (GDPR).
  • Leadership and Experience: Experience leading a validation project, authoring validation plans, and using Electronic Document and Quality Management Systems such as Veeva, Qualio, or Master Control.
  • Test Coordination and Management: Experience with test coordination and testing management, including training users on executing test protocols and managing test results through the process.

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