Senior Validations Officer

As a Validation Specialist, your primary focus will be supporting the engineering team by defining, executing, and reporting on validation activities related to facilities, utilities, and process equipment. This includes conducting IQ, OQ, and PQ studies to ensure optimal performance and output. Additionally, we are expanding our capabilities with the addition of a new Drug Product facility. Develop, implement, and report on qualification, re-qualification, and validation studies to establish and maintain the validated status of facilities, utilities, equipment, and processes in accordance with internal procedures, regulatory requirements, and industry standards. Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc., ensuring risks are properly identified and documented. Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment. Knowledge of current regulatory requirements and industry standards related to validation activities. Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.