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.