Validation Engineer at ALLIANCE BIOTECH SOLUTIONS LLC – Raleigh, North Carolina

Alliance Biotech Solutions is currently hiring multiple Cleaning Validation Engineers to supports the execution and coordination of cleaning validation activities across manufacturing equipment and processes in GMP-regulated environments. This role is responsible for protocol development, execution, deviation support, and documentation while ensuring compliance with site procedures, FDA, GMP, and global regulatory standards.

The Cleaning Validation Engineer will work cross-functionally with Manufacturing, Quality, Quality Control and Engineering teams to support the cleaning validation, including cycle development, hold time studies, and lifecycle management. The role requires strong technical writing, analytical thinking, and hands-on execution.

Key Responsibilities:

• Execute and support cleaning validation activities, including protocol development, execution, and final report generation
• Support Cleaning Validation, Clean Hold Time (CHT), and Soil Hold Time (SHT) studies from planning through completion
• Perform on-the-floor validation execution, including sampling and coordination of cleaning activities
• Support cleaning validation for manufacturing equipment including process vessels, CIP systems, autoclaves, and parts washers
• Investigate deviations, discrepancies, and out-of-specification results; perform root cause analysis and support corrective actions
• Ensure timely closure of validation-related deviations and documentation
• Collaborate with cross-functional teams to ensure validation activities align with project timelines and operational needs
• Author and review validation protocols, reports, and technical documentation
• Support execution within electronic validation systems such as KNEAT

Skills & Experience:

• 2+ years of experience supporting cleaning validation in GMP-regulated environments
• Experience with electronic validation systems such as KNEAT or similar platforms
• Strong understanding of GMP regulations and global compliance standards
• Ability to interpret technical documentation including P&IDs and process flow diagrams
• Strong technical writing and documentation skills
• Demonstrated analytical and problem-solving capabilities
• Ability to work independently and manage multiple priorities in a dynamic environment
• Strong communication skills with the ability to collaborate cross-functionally