CSV Engineer – Automation

Role: CSV Engineer – AutomationLocation: Remote Type: Contract Role SummaryWe are seeking an experienced Computerized System Validation (CSV) Engineer to support the validation of automated manufacturing equipment, associated software, and system integrations within a regulated Life Sciences environment.The role will collaborate closely with equipment vendors, Quality Assurance, Automation, IT, and other cross-functional teams to ensure computerized systems and automated processes meet applicable FDA and GxP requirements throughout the project lifecycle. Key ResponsibilitiesExecute CSV activities for automated equipment, computerized systems, and associated software.Support the validation of integrations with MES, reporting/analytics platforms, and other site systems.Collaborate with equipment and software vendors to understand system architecture, functionality, configuration, and capabilities.Develop, review, and maintain validation documentation, including:User Requirements Specifications (URS)Risk AssessmentsIQ/OQ/PQ protocols and reportsValidation Plans and ReportsTraceability and supporting validation documentationCoordinate validation activities with Quality, Automation, IT, Engineering, and other relevant stakeholders.Support the management and resolution of deviations, change controls, CAPAs, and post-implementation issues.Ensure computerized systems remain compliant and in a validated state throughout their operational lifecycle.Participate in project meetings, provide validation status updates, and support timely resolution of validation-related issues.Ensure validation activities are performed in accordance with applicable regulatory requirements, company procedures, and established quality standards. Required Skills & ExperienceExperience in Computerized System Validation (CSV) within the Life Sciences, Pharmaceutical, Biotechnology, or similarly regulated industries.Strong working knowledge of:FDA 21 CFR Part 11GAMP 5FDA CSV requirementsData Integrity principles, including ALCOA+Experience with automation systems, equipment validation, computerized systems, and system integrations.Exposure to MES, Power BI/reporting platforms, PLC/HMI systems, or manufacturing automation technologies.Experience working with equipment/software vendors and cross-functional technical and Quality teams.Strong understanding of risk-based validation methodologies and GxP compliance.Excellent stakeholder management, communication, documentation, and vendor coordination skills.Ability to work independently in a remote, project-based environment while collaborating effectively with distributed teams.