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.