Computer Systems Validation Specialist

7 days ago

Bothell, Washington, United States Katalyst Healthcares & Life Sciences Full time
Job Title: Computer System Validation Engineer

We are seeking a highly skilled Computer System Validation Engineer to join our team at Katalyst Healthcares & Life Sciences. As a key member of our team, you will be responsible for leading and executing validation activities for GxP electronic systems and applications.

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.
  • Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
  • Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required).
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 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 ensure they meet regulatory requirements.
  • Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.
  • Knowledge of IT service management platforms to support change IT operational events (i.e. ServiceNow).
  • Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
  • Strong technical and problem-solving skills and the ability to work independently.
  • Demonstrated success working in a high-performing, business results-driven environment.

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