Computer System Validation Engineer

Company: STAFTONIC LLC
Location: Millersville
Posted on: July 2, 2025

Job Description:

Key Responsibilities: Lead validation of computerized systems (Blue Mountain RAM, Veeva, Kneat, EMS/BMS). Prepare and execute CSV documentation (VMP, SOPs, IQ/OQ/PQ, test scripts). Ensure compliance with 21 CFR Part 11 and GAMP 5. Review vendor documents and support system implementation. Collaborate with QA, Engineering, Automation, and IT teams. Requirements: 10 years of CSV experience, including greenfield facility projects. Strong background in cell/gene therapy and GMP environments. Hands-on with Blue Mountain, Veeva, Kneat, and automation systems. Excellent documentation and communication skills.

Keywords: STAFTONIC LLC, Wilmington , Computer System Validation Engineer, IT / Software / Systems , Millersville, Delaware

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