Validation Engineer I

Validation Engineer I is responsible for generating and executing validation protocols, creating summary reports, and coordinating validation activities in FDA-regulated biopharmaceutical environments. The role supports cross-functional teams, assists in validating equipment, utilities, facilities, processes, and automation systems (IQ/OQ/PQ/CV/PV), maintains GMP system inventories, performs risk assessments, troubleshoots discrepancies, and adheres to SOPs and regulatory requirements. On-site collaboration with departments, clients, CMOs, and vendors is required, with a focus on ensuring compliant validation activities and process improvements in a cGMP environment. The position includes on-site duties and potential exposure to PPE requirements.