Validation Engineer

Scope of Work

Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes.

Risk Assessment: Lead/participate in GxP risk assessments for the implemented changes.

Protocol Development & Execution: Author, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for the modified TwinCAT systems.

Requirements Traceability: Develop and maintain Requirements Traceability Matrices (RTM).

Deviation Management: Investigate, document, and manage deviations encountered during validation activities; support root cause analysis and CAPA development.

Reporting: Author Validation Summary Reports (VSR) and other validation lifecycle documentation.

Compliance: Ensure all validation activities and documentation meet internal procedures and regulatory requirements.