Job Summary

The Process Validation Engineer I supports the design, execution, and documentation of process validation activities to ensure compliance with regulatory requirements, quality standards, and operational efficiency. This role partners with cross-functional teams to validate new and existing processes, analyze data for process capability, and drive continuous improvement within a cGMP-regulated environment.

Job Responsibilities

• Develop, execute, and review process validation protocols (e.g., PV, PPQ) and reports.
• Perform risk assessments (e.g., FMEA, HACCP) to identify critical parameters and ensure process control.
• Analyze and interpret validation data to establish process capability and consistency using statistical tools.
• Author and maintain validation protocols, reports, and SOPs in compliance with FDA, EU, and ICH guidelines.
• Collaborate with R&D, Manufacturing, Engineering, and QA/QC on technology transfer, new product introductions, and process improvements.
• Investigate process deviations, support CAPA implementation, and recommend corrective actions.
• Evaluate and implement technologies to enhance process robustness and reliability.
• Ensure audit readiness by maintaining complete, accurate, and compliant documentation.
• Support internal and external inspections by demonstrating validated processes.
• Provide training on validation procedures, protocols, and best practices.
• Prepare periodic summaries and metrics of validation activities.
• Perform other duties as assigned.