Manager I, Validation

Job 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 subje...