Cleaning Validation Specialist I

Target PR Range: 35-45/hr DOE Cleaning Validation Specialist Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies. * Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies * Supports non-traditional work schedule based on project and business needs * Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program * Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages. * Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process. * Proficient with KNEAT execution * Design and develop cleaning procedures for new products and manufacturing equipment. * Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures. * Supports the periodic review of cleaning validation studies. * Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises. * Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan. * Trains manufacturing and QC/QA personnel on cleaning validation documentation.