Validation Project Lead

1 week ago


Melrose Park, Illinois, United States Fresenius Kabi USA, LLC Full time
Job Overview
The Validation Project Lead at Fresenius Kabi USA, LLC is responsible for coordinating validation projects from proposal to completion. This role requires strong technical expertise and problem-solving skills to ensure compliance with cGMP and regulatory requirements. The successful candidate will have 10 years of related experience in a cGMP facility and 5 years of leadership experience with direct reports.

Responsibilities
• Establishes the Validation strategy for new processes/equipment and translates those requirements into validation protocols and standard operating procedures.
• Develops, maintains, and updates the VMP for the overall project.
• Oversees activities of project personnel to include assignment of tasks, scheduling, and coordination across plant functional areas.
• Conducts deviation investigations to identify root causes and define corrective actions (CA), maintaining compliance within the company.
• Interfaces with FDA or other regulatory bodies relative to equipment and control system issues or critical processes as the primary Validation interface.

Requirements
• Bachelor's degree in science or engineering field or a combination of education, training, and experience.
• 10 years of related experience in a cGMP facility.
• 5 years of leadership experience with direct reports.
• Experience in cGMP CA/PA, root-cause analysis, risk assessment, and investigation tools and techniques.

Estimated Salary: $150,000 per year based on qualifications and location.

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