mputer System Validation Plans (CSV Plans)· Qualification Plans and Test Plans· Requirements Specifications (URS/RS)· Functional Specifications (FS)· Design Specifications (DS)· Requirements Traceability Matrices (RTM)· Code Review Documentation· Test Specifications and Test Scripts· Validation Summary Reports· FAT Oversight Documentation and Leveraging Assessments· Vendor Compliance Review Reports· SDLC Templates and Validation Documentation Standards· Qualification and Validation Execution Records· Validation Schedules and Document Trackers· Risk Assessments and Compliance Assessments· Audit and Inspection Support Documentation· Project Status Reports and Stakeholder Updates· Final Validation Approval and Project Closeout DocumentationRequired Qualifications and Competencies· Bachelor's Degree in Computer Science, Engineering, Automation, Information Technology, or related discipline.· Minimum 3 years of Computer System Validation experience within Life Sciences or Pharmaceutical Manufacturing.· Expert knowledge of GAMP5 validation methodology.· Strong understanding of SDLC processes and validation lifecycle requirements.· Experience developing and executing validation documentation within GMP-regulated environments.· Demonstrated experience reviewing and approving validation deliverables.· Experience working with vendors and system integrators on regulated projects.· Strong stakeholder management, communication, and technical writing skills.· Ability to operate effectively within cross-functional project teams.

Horizon Controls Group