CSV Engineer
Role Overview
Responsible for Computer System Validation activities within a pharmaceutical manufacturing environment.
Responsible for the development and execution of key validation and quality documentation including Qualification Plans, Test Plans, Requirements Traceability Matrices (RTMs), and Validation Summary Reports, ensuring full compliance with GMP, GAMP5, and regulatory standards.
Worked closely with Automation, IT, Quality, and third-party vendors to support delivery of digital manufacturing systems and ensure alignment with project validation strategies and quality requirements.
Represented the CSV function at project, automation, and IT meetings while supporting overall project execution and compliance objectives.
Responsibilities
- Delivered full Computer System Validation (CSV) lifecycle activities for SynTQ Syncade, including development and execution of test scripts, validation protocols, and Requirements Traceability Matrices (RTM) covering recipe management, electronic batch records (EBR), and manufacturing workflows.
- Led validation of MES configurations, master data, audit trails, and electronic signatures in line with GMP, GAMP5, and 21 CFR Part 11 requirements, ensuring full data integrity and regulatory compliance.
- Coordinated FAT/SAT and system acceptance testing for MES implementations and upgrades, including end-to-end integration with automation systems and resolution of validation deviations in collaboration with vendors and site teams.
- Developed and maintained Qualification Plans and Validation Test Plans aligned with overall C&Q strategy.
- Created and managed SDLC validation templates and documentation including:
- User & Functional Requirements Specifications (URS/FRS)
- Design Specifications
- Requirements Traceability Matrices (RTM)
- Code Review Documentation
- Test Scripts & Test Specifications
- Validation Summary Reports
- Ensured all validation deliverables complied with internal quality standards and regulatory requirements.
- Worked closely with Digital Data & Quality teams to ensure data integrity and compliance expectations were achieved.
- Provided FAT oversight and performed leveraging assessments for vendor-supplied systems.
- Supported project scheduling, validation tracking, and document management activities.
- Collaborated with suppliers, system integrators, and project stakeholders to ensure adherence to validation standards and project timelines.
- Supported project meetings and coordinated communication between Automation, IT, Quality, and Engineering teams regarding validation activities.
Qualifications
Technical Skills & Experience
- 5+ years’ experience in Computer System Validation within pharmaceutical or life sciences manufacturing environments
- Expert knowledge of GAMP5 methodology
- GMP & Regulatory Compliance
- SDLC Documentation & Validation Lifecycle
- FAT/SAT Oversight
- Requirements Traceability Matrix (RTM)
- Validation Planning & Execution
- Vendor & Stakeholder Management
- Data Integrity & Quality Compliance
Technical Skills & Experience
- 5+ years’ experience in Computer System Validation within pharmaceutical or life sciences manufacturing environments
- Expert knowledge of GAMP5 methodology
- GMP & Regulatory Compliance
- SDLC Documentation & Validation Lifecycle
- FAT/SAT Oversight
- Requirements Traceability Matrix (RTM)
- Validation Planning & Execution
- Vendor & Stakeholder Management
- Data Integrity & Quality Compliance
