Validation Engineer

Position Title: Validation Engineer

Work Location: Tucson, AZ 85755

Assignment Duration: 12 Months

Work Schedule: 40 hours/week

Work Arrangement: Onsite

Position Summary:

* 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.

Key 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.

Qualification & Experience:

* 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.