Validation Engineer

We are seeking a proactive Validation Engineer with 1–3 years of experience in a regulated manufacturing environment, preferably within medical devices, pharmaceutical, biotech, or FDA-regulated industries, to ensure compliance and drive operational integrity.

This is an on‑site position focused on process validation and process verification activities. The ideal candidate will possess strong technical writing, analytical, and problem‑solving skills, along with a solid understanding of process validation principles, cGMP requirements, and regulatory standards.

• 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.