CSV Engineer

• 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
  

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 Leads 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.

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

Bachelors 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.