Job Title: Computer System Validation Engineer

Location: Dallas, TX

About the Opportunity:

Our client is looking for a Computer System Validation Engineer to contribute to critical projects ensuring compliance and quality of computerized systems. This role is ideal for a highly skilled professional with a passion for validation and regulatory compliance who thrives in a dynamic, team-oriented environment.

Key Responsibilities:

• Validation Deliverables : Develop, review, and execute comprehensive validation plans, risk assessments, and traceability matrices for computerized systems.
• Documentation Compliance : Author and maintain essential documentation to meet CSV standards and ensure regulatory compliance.
• Validation Processes : Prepare or review critical validation documents, including:
• Validation Strategy Plans
• User Requirement Specifications (URS)
• Functional Specifications, Software Design Specifications, Configuration Documents
• Qualification Protocols (IQ, OQ, PQ) and Test Specifications
• SOPs, Traceability Matrices, and Risk Analyses
• Validation Reports, Change Controls, Deviations, and Event Reports
• Impact Assessments : Analyze proposed changes to systems and determine necessary validation efforts.
• Validation Strategy : Define and execute strategies for the implementation and maintenance of computerized systems.
• Collaboration : Work closely with cross-functional teams, including Information Systems, software assurance, business users, and suppliers, to deliver compliant and successful project outcomes.
• Expert Guidance : Serve as a subject matter expert, providing strategic advice and consultation on all aspects of CSV.

Candidate Requirements:

• Demonstrated experience in Computer System Validation within regulated environments.
• Comprehensive knowledge of CSV standards, risk management, and compliance protocols.
• Strong collaborative and communication skills for effective teamwork and stakeholder engagement.