Validation Engineer

Ideal Candidate: 5+ YOE with a B.S. in Science, Engineering, and Pharmacy areas.Standard Hours - hours may vary to support manufacturing (early/later shifts, possible weekends)Cleaning Validation Specialist I Job DescriptionCoordinate 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 studiesSupports non-traditional work schedule based on project and business needsFamiliar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV programDemonstrated 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 executionDesign 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.