Validation Engineer

Validation Engineer ROCGJP

• Hourly pay: $42/hr
• Worksite: Leading biotechnology company (Tucson, AZ 85755 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program
• 40 hours/week, 12 Month Assignment

A leading biotechnology company is seeking a Validation Engineer ROCGJP to support process validation activities in a regulated manufacturing environment. This role will focus on ensuring compliance, supporting operational integrity, and driving continuous improvement initiatives within FDA-regulated operations.

• Develop, review, and execute process validation and process verification protocols, reports, and supporting documentation for new and existing manufacturing processes.
• Conduct risk assessments, analyze validation data, and ensure compliance with FDA, ISO, cGMP, and internal quality and regulatory requirements.
• Collaborate cross-functionally with Manufacturing, Quality, and Design Transfer Operations teams to resolve validation issues, implement corrective actions, and support process optimization initiatives.
• Maintain validation documentation and traceability for audits and inspections while providing training and guidance to manufacturing and quality personnel on validation procedures and best practices.
• Support continuous improvement efforts and additional validation or quality-related projects as assigned by management.

• 1-3 years of experience in a regulated manufacturing environment, such as medical devices, pharmaceutical, or biotech industries, is preferred.
• Bachelor’s Degree in Engineering or Life Science.
• Strong understanding of process validation principles, methodologies, and industry standards.
• Knowledge of cGMP, FDA, ISO, and related regulatory requirements.
• Strong technical writing, analytical, troubleshooting, and problem-solving skills.