Manager I, Validation

Description POSITION SUMMARY: The Manager I, Validation, is responsible for the development, implementation, and continuous improvement of the validation and calibration programs in compliance with applicable regulatory and quality standards to maintain audit readiness, ensure alignment with internal quality systems, and support regulatory compliance. This role is also responsible for providing leadership and oversight for validation and calibration activities across facilities, utilities, equipment, computerized systems, test methods, and laboratory and manufacturing processes, and ensures that risk-based validation strategies are defined and executed throughout the product/process lifecycle. DUTIES AND RESPONSIBILITIES Develop, implement, and maintain MSD's validation and calibration programs for manufacturing operations, laboratory services, facilities, equipment, and computerized systems. Implement and maintain risk management practices to support validation and calibration decision-making. Establish and maintain Master Validation Plans (MVPs) for all manufacturing facilities, equipment, and processes to define the scope and drive the timing of validation activities. Provide subject matter expertise for new equipment, systems, product introductions, and facility expansions. Manage validation and calibration schedules to ensure timely execution. Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV). Review and approve validation protocols, reports, calibration records, and associated documentation. Manage the site calibration program, including asset classification, calibration intervals, traceability standards, and compliance requirements. Ensure timely investigation and resolution of calibration out-of-tolerance (OOT) events and validation deviati