Validation of Sterilization processes and equipment including moist heat, dry heat, gamma, and ethylene oxide associated with the manufacture of pharmaceutical or medical devices to assure compliance with cGMP’s, FDA’s and BLP’s guidelines. Job assignments are to be completed without a considerable amount of supervision or coaching.
In addition, Validation of manufacturing equipment, facilities, utilities and computerized systems is highly desirable.
9. Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and processes.
Experience in one or all of the following types of validation desired: Sterilization processes including moist heat, dry heat, gamma, and ethylene oxide. Strong Project Management, organizational, analytical, computer, writing and communication skills. Knowledge of aseptic processing highly desired. Excellent logical/mechanical aptitude desired. Knowledge of cGMP regulations and latest validation guidelines. Able to handle multiple priorities in a fast-paced environment. Able to work extended/odd hours around manufacturing schedule required.