Computer Systems Validation Specialist

Job Summary

Supporting Product Lifecycle Management (PLM) implementation, the remote Computer Systems Validation Specialist will develop validation documentation, assist with system configuration, execute user acceptance testing, and ensure compliant system adoption in a regulated environment on a contract basis.

Key responsibilities

• Develop user requirements, functional requirements, and validation documentation for PLM implementation
• Support PLM configuration, workflow reviews, data mapping, and system readiness activities
• Author CSV deliverables and collaborate with IT, Quality, vendors, and project teams to support system implementation and validation activities

Required qualifications

• Bachelor of Science in Computer Science, Engineering, Business, or a related discipline
• 3+ years of experience in Computerized System Validation (CSV/CSA) with strong document authoring experience
• Experience with GxP/FDA-regulated systems, requirements gathering, functional analysis, and User Acceptance Testing (UAT)
• Experience supporting QMS, PLM, or document management systems; prior PLM implementation and validation experience preferred
• Preferred: Experience with PLM software such as Agile or MasterControl and knowledge of cGMP, cGDP, and 21 CFR Part 11 regulations