Computer Systems Validation Specialist

7 days ago

Bothell, Washington, United States Omni Inclusive Full time
Job Title: Computer Systems Validation Specialist

Omni Inclusive is seeking a skilled Computer Systems Validation Specialist to join our team. As a CSV Specialist, 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 global/site-specific system technology and validation teams.
  • Develop and manage validation deliverables for site-level electronic systems and applications that integrate with enterprise systems.
  • Ensure that routine tasks supporting validation of electronic systems and applications supporting clinical and commercial drug product manufacturing are documented in accordance with relevant company procedures and health authority regulations.
  • Partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables.
  • Lead computer system validation efforts for new system implementations and changes to existing systems.
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.
  • Strong interpersonal skills to work with teams in different functions and organizations.
Preferred Qualifications:
  • Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
  • Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems.
  • Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.

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