CSV Engineer

Engagement Summary

• Objective: Provide Computer System Validation (CSV) leadership and support for capital projects, ensuring all automated and computerized systems are implemented, qualified, and validated in compliance with quality standards, GAMP5, SDLC methodology, and applicable regulatory requirements.
• Engagement Type: Time-and-materials

Scope and Core Responsibilities

• Serve as the Computer System Validation (CSV) Subject Matter Expert (SME) for capital projects.
• Provide a standardized CSV approach across projects in alignment with the CSV Lead's validation strategy.
• Work closely with Automation, IT, Quality, Engineering, and teams responsible for system delivery and implementation.
• Collaborate with vendors, suppliers, and system integrators to ensure compliance with validation and quality requirements.
• Develop and maintain Qualification Plans, Validation Plans, and Test Plans aligned with project Commissioning & Qualification (C&Q) strategies.
• Develop, review, and approve Software Development Lifecycle (SDLC) deliverables, including:

ü Requirements Specifications

ü Functional Specifications

ü Design Specifications

ü Requirements Traceability Matrices (RTM)

ü Code Review Documentation

ü Test Specifications and Test Scripts

ü Validation Summary Reports

ü Other Qualification And Validation Documentation As Required

• Ensure all CSV deliverables comply with quality procedures, GAMP5 guidance, SDLC requirements, and applicable regulatory standards.
• Partner with Digital Data & Quality (DDQ) teams to ensure all data integrity and compliance requirements are addressed.
• Review vendor documentation and validation packages to confirm compliance with standards and leveraging requirements.
• Provide Factory Acceptance Testing (FAT) oversight and perform validation leveraging assessments.
• Support project teams with CSV guidance, document generation, review, and execution activities.
• Participate in project planning activities and provide input into realistic project schedules and validation trackers.
• Represent the CSV function at project, automation, IT, quality, and stakeholder meetings.
• Facilitate communication between project stakeholders regarding validation strategy, documentation, testing, and compliance requirements.
• Support regulatory inspections, audits, and quality reviews as required.

Deliverables

• Computer 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 Documentation

Required 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.