Validation Engineer

*** 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 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.

QUALIFICATIONS

--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.