Position Overview
We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity.
RESPONSIBILITIES
--Develop, write, review, and execute process validation/process verification protocols and reports.
--Conduct risk assessments and develop validation strategies for new and existing processes.
--Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
--Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions.
--Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency.
--Ensure compliance with FDA, ISO, and other relevant regulatory gui...