CSV Engineer – Automation

Role: CSV Engineer – Automation

Location: Remote

Type: Contract

Role Summary

We 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 Responsibilities

• Execute 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 Assessments
• IQ/OQ/PQ protocols and reports
• Validation Plans and Reports
• Traceability and supporting validation documentation
• Coordinate 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 & Experience

• Experience in Computerized System Validation (CSV) within the Life Sciences, Pharmaceutical, Biotechnology, or similarly regulated industries.
• Strong working knowledge of:
• FDA 21 CFR Part 11
• GAMP 5
• FDA CSV requirements
• Data 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.