Computer Validation Specialist

4 weeks ago

Bothell, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • The Computer Systems Validation (CSV) Analyst works cross-functionally to lead and execute validation activities for GxP electronic systems, with a focus on Systems MES (Emerson) integrations and recipe functions.
  • This role is an individual contributor with occasional oversight of contract resources on a project basis.
  • The CSV Engineer partners with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for site-level electronic systems and applications that integrate with enterprise systems.
  • The CSV Engineer has primary responsibilities to ensure that routine tasks supporting validation of electronic systems and applications supporting clinical and commercial drug product manufacturing are documented in accordance with the relevant company procedures and health authority regulations.
  • This includes leading computer system validation efforts for new system implementations and changes to existing systems as well as coordinating system validation assessments, periodic reviews, and audit activities
  • Master's Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR
  • Bachelor's Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
Requirements:
  • Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
  • Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
  • 3-5+ years' experience in performing periodic review of computerized systems.
  • Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems.
  • Strong critical thinking and problem-solving skills
  • Strong interpersonal skills to work with teams in different functions and organizations.
  • GXP Equipment Validation
  • Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES etc.), coordinating with the global/site specific system technology and validation teams.
  • Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.
  • Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews/Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.
  • uthor, review and/or approve applicable CSV documentation.
  • Perform or oversee test script execution efforts, including defect management.
  • Ensure validation test strategies align with internal procedures and requirements for intended use.
  • ssist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
  • Experience in following CSV methodology for system evaluations, changes, and implementations.
  • bility to work independently.
  • Other related duties as assigned.

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