Computer System Validation Engineer

Computer System Validation (CSV) / Computer Software Assurance (CSA) Specialist

Key Responsibilities

• Own the validation approach, risk assessment, scope, and testing strategy using GAMP 5 and Computer Software Assurance (CSA) principles, with a focus on patient safety, product quality, and data integrity.
• Lead validation lifecycle activities for GxP-regulated systems, including:
• Requirements and specifications
• Traceability
• Testing and test execution
• Deviations and investigations
• Change control
• CAPA support
• Audit readiness activities
• Apply GxP expectations, GAMP 5, and CSA principles across traditional, Agile, SaaS, cloud-hosted, and modern digital platforms.
• Determine when supplier documentation and testing evidence can be leveraged based on:
• Risk assessment
• Intended use
• Vendor qualification/assessment
• Release impact
• Quality agreements
• Support:
• Infrastructure Qualification (IQ)
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• Functional and system risk assessments
• IT quality, compliance, and governance activities in regulated Life Sciences environments
• Support both Agile and Waterfall software development lifecycle activities.
• Assess data integrity controls, including:
• Audit trails
• User access management
• ALCOA+ principles
• Data lineage
• Interfaces and integrations
• Manual processes
• Connected systems
• Support validation of AI/ML-enabled systems by evaluating:
• Intended use
• Data quality
• Explainability
• Human oversight
• Drift monitoring
• Revalidation triggers
• Apply knowledge of pharmacovigilance processes, system workflows, regulatory requirements, and supporting documentation to validation activities.
• Coordinate validation activities across multiple applications and systems while managing schedules, dependencies, deliverables, and stakeholder communications.
• Support:
• IQ/OQ execution
• User story development
• Test planning
• Training material development
• Content authoring
• Provide project and operational support for eLearning and Learning Management Systems (LMS), including implementation, integration, maintenance, and sustainability activities.
• Track assigned actions, manage deadlines, and proactively escalate risks and issues.

Required Qualifications

• Experience working with GxP-regulated systems and Computer System Validation (CSV).
• Strong knowledge of:
• GAMP 5
• CSA (Computer Software Assurance)
• Data Integrity
• Risk-Based Validation
• Experience preparing and managing:
• Validation documentation
• Requirements Traceability Matrix (RTM)
• Test scripts and execution
• Deviations
• Change management
• Audit readiness activities
• Experience working with:
• SaaS platforms
• Cloud-hosted applications
• Qualified cloud infrastructure
• Strong hands-on experience with CSV and/or CSA in Agile delivery environments.
• Experience applying a risk-based validation approach to:
• Agile releases
• Features
• User stories
• Product increments
• Experience integrating quality, compliance, and validation activities into Agile and Hybrid SDLC frameworks.
• Experience in:
• IT Quality
• IT Compliance
• IT Risk Management
• Quality Oversight
• Strong stakeholder management, documentation, coordination, and delivery management skills.
• Practical knowledge of infrastructure and network components, including:
• Servers
• Virtual Machines (VMs)
• Storage systems
• Databases
• Load balancers
• Networking fundamentals
• Understanding of cloud service models, including:
• Infrastructure as a Service (IaaS)
• Platform as a Service (PaaS)
• Software as a Service (SaaS)
• Hybrid Cloud
• Managed Services

Preferred Qualifications

• Hands-on experience with:
• JIRA
• qTest
• ServiceNow
• ValGenesis
• Experience supporting eLearning Platforms or Learning Management Systems (LMS).
• Experience developing:
• Training materials
• User guides
• eLearning content
• Experience within Life Sciences, Pharmaceutical, Biotechnology, or Healthcare environments.
• Familiarity with validation and compliance requirements for AI/ML-enabled systems.