Engineer Pharma Validation

Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing revalidation, engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations of applicable products. This position requires up to 40% travel both international and domestic. Job Description Responsibilities: Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic manufacturing. Perform engineering studies to determine if projects are feasible. Develop, prepare and install equipment and revise test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices. Develop and execute cleaning validations. Responsible for IQ/OQ and PQ phases. Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols. Develop timelines for all projects and ensure that deadlines and g