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Computer System Validation Engineer

Palo Alto, CA · Biotech/Pharmaceutical
Title: Computer System Validation Engineer

Type of role: Contract (1099,C2C or W2)
Duration: 12+ months
Location: Palo Alto, CA

 
Our client is looking for a CSV Engineer. ARGUS Drug Safety is strongly preferred, but not necessary.

Minimum 6+ years of experience in computerized system validation within a regulated environment.
Candidate must have strong understanding of CSV methodology related to Inhouse, Hosted and SaaS application. In addition to thorough working knowledge of GAMP, Part 11, Annex 11, Risk Strategy/management.
 
Knowledge of Argus is a plus, and preferred. But for the candidate who is strong in CSV without Argus exp., our customer is willing to train the candidate in Argus.
  • Proven ability to lead validation activities of complex IT projects. 
  • Possess system quality and compliance knowledge of GxP regulations (21 CFR Part 11, Annex 11 & GAMP5)
  • Hands-on authoring/ review/ approval of computer system validation deliverables.
  • Author Validation Plan, Design Specification, IQ, OQ & PQ Protocols, Traceability Matrix and Validation Summary Reports for assigned projects. 
  • Manage authoring of Risk Assessments. 
  • Manage authoring, dry running, & review & approval of IQ, OQ and PQ test scripts. 
  • Manage preparation of all validation deliverables for presentation to QA for approval. 
  • Experience in creation/maintenance & implementation of SOPs.
  • Experience with Validation Testing (test execution), experience in Pharma Domain.
  • Write up and manage resolution and final disposition of all Deviations identified during test execution. 
  • Demonstrated strong organizational, verbal, written and presentation skills.
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