The RoleThe Cleaning Validation Specialist is responsible for coordinating the cleaning validation activities , including but not limited to preparing and executing the protocols and reports for cleaning validation.This position will lead all efforts for cleaning method development and will work closely with Analytical Development team for executing the cleanability studies.This position will maintain the “Cleaning validation matrix” and will work with cross functional teams for introduction and assessment of new project.Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation.Perform investigation of deviations / discrepancies. Oversees and reviews validation area processes.Design and develop cleaning procedures for new products and manufacturing equipment.Provide technical support to cleaning activities associated with the manufacturing process.Lead the cleaning validation program and activities to keep up with manufacturing requirements and control cleaning related failures.Use of cleaning agents and the establishment of sound cleaning practices within new or refurbished manufacturing rooms and cleaning/sampling suites areas.Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.Investigates and conducts troubleshooting and root cause analysis of cleaning related incidents, deviations and CAPA. Complete Action items as assigned.Create, and review manufacturing cleaning Working Instructions, Standard Operating Procedures, Batch Records, Study Protocols and Cleaning Validation documentations.Supports the periodic review of cleaning validation studies.Issues Change Controls required for the implementation of cleaning procedure changes, as needed.Trains manufacturing and QC/QA personnel on cleaning validation documentation.Perform cleanability studies and visible limit studies to determine the appropriate detergent and cleaning limits for new product development.Conduct data analysis in Minitab to draw conclusions for various cleaning studies.Conduct cleaning risk assessment on manufacturing equipment to determine difficult-to-clean surfaces and potential swab locations. The CandidateMasters degree in a scientific field or an equivalent combination of education and experience.Minimum three (3) years of experience in Production or validation related fieldCompetent in the use of Microsoft Office packages including Word, Excel, PowerPoint, Outlook.Experience and knowledge of within GMP regulated environment/departmentExperience and knowledge of statistical software like Minitab.Preferable experience of working in a Solid oral dose manufacturing environment or equivalent experience in another role.