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Computer Systems Validation Specialist

2 months ago

Bothell, Washington, United States Futran Solutions Full time
Job Title: Computer Systems Validation Specialist

Futran Solutions is seeking a skilled Computer Systems Validation Specialist to join our team. As a key member of our validation team, 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 (SME) 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 [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.).
  • Ability to effectively communicate with both technical and non-technical team members.
  • Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication.
  • Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
Education and Experience:
  • Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.
  • Must have experience with Computer system validation of MES.
  • Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.