Senior Validation Engineer

Leading validation activities in a GMP-regulated environment, the full-time Senior Validation Engineer will develop, execute, and manage validation lifecycle documentation while providing QA/Validation oversight for Manufacturing Execution System (MES) and Electronic Batch Record (eBR) implementations. Key Responsibilities Lead the generation and execution of validation lifecycle documentation for equipment, utilities, and computerized systems Provide QA/Validation oversight for MES and eBR implementation, qualification, and lifecycle activities Review and approve validation documentation, ensuring compliance with regulatory requirements and internal quality standards Required Qualifications Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field 7-11 years of experience in the biotechnology, pharmaceutical, or medical device industry Strong knowledge of FDA cGMP requirements and risk-based validation methodologies Advanced expertise in equipment qualification, process validation, and computerized systems validation Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, or similar systems is preferred