Engineer Pharma Validation

Job description

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. Lead the authoring and executing of protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results. In addition, this role will coach and assist Pharma Validation Engineers through the validation process. Responsibilities: Qualifications: - Responsible for revalidation, engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations of applicable products in an FDA controlled environment. Plan, communicate and lead scientifically sound qualification/validation strategies for large scale projects. Perform engineering studies to determine if projects are feasible. - Suggest OEE Improvements and suggestions as a member of the continuous improvement team. - Communicate with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regard to the needs and status of assi...