Validation Engineer

Industry : Medical Devices

Title : Validation Engineer I

Job ID : ROCGJP00037522

Location : Tucson, AZ

Duration : 12 months contract (High Chances of Extension)

Description :

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. This is an on-site position that focuses on process validation.

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.