Computer Systems Validation Specialist

3 weeks ago


Bothell, Washington, United States Katalyst Healthcares & Life Sciences Full time
Job Description

At Katalyst Healthcares & Life Sciences, we are seeking a highly skilled Computer Systems Validation Specialist to join our team. As a key member of our IT department, you will be responsible for leading and executing validation activities for GxP electronic systems and applications.

Key Responsibilities:

  • Lead routine CSV lifecycle activities, coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
  • Author, review, and/or approve applicable CSV documentation.
  • Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
  • Support health authority inspections as a subject matter expert for routine CSV lifecycle activities.

Requirements:

  • Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
  • Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, SOPs, etc.).
  • Ability to effectively communicate with both technical and non-technical team members.
  • Strong interpersonal skills, especially regarding teamwork, client focus, verbal and written communication.
  • Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and meet regulatory requirements.

About Us:

Katalyst Healthcares & Life Sciences is a leading provider of healthcare and life sciences solutions. We are committed to delivering high-quality services and products that meet the needs of our clients.


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