Validation Engineer

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 guidelines, as well as adherence to internal requirements.
• Provide training and guidance to manufacturing and quality personnel on validation processes and procedures.
• Maintain process validation documentation and ensure traceability and accessibility for audits and inspections.
• Other duties as assigned by management.

• Bachelor's Degree in Engineering or Life Science.
• Strong technical writing, analytical, and problem-solving skills.
• Knowledge of cGMP and regulatory standards.
• Strong understanding of process validation principles, techniques, and industry standards.

Pay ranges between $32-42/hr based on experience