Computer Systems Validation Specialist

6 days ago

Bothell, Washington, United States Omni Inclusive Full time
About the Role

Omni Inclusive is seeking a highly 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, with a focus on Systems MES (Emerson) integrations and recipe functions.

Key Responsibilities
  • Lead site-specific CSV activities for computer system integration projects, coordinating with the global/site specific system technology and validation teams.
  • Develop and maintain strong knowledge of GAMP / risk-based approaches to validation, including Computer Software Assurance (CSA) and electronic record / signature management practices.
  • Author, review, and/or approve applicable CSV documentation, including validation plans, requirements, specifications, assessments, test scripts, reports, and trace matrices.
  • Perform or oversee test script execution efforts, including defect management, to ensure validation test strategies align with internal procedures and requirements for intended use.
  • Collaborate with business owners and technical system owners to develop requirements and specifications for computerized systems used in GxP operations.
  • Ensure compliance with company procedures and regulatory requirements for routine CSV lifecycle activities, including system periodic validation lifecycle and audit trail / user access reviews.
Requirements
  • 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.
  • Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
  • Strong critical thinking and problem-solving skills, as well as strong interpersonal skills to work with teams in different functions and organizations.
  • Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems and GXP Equipment Validation.

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