Enter Job Description... • • Validate manufacturing processes, Develop Equipment Cleaning methodology within acceptance criteria. • • Developed Equipment Critical cleaning parameter as per Notebook study Performance. • • Adapt machine or equipment design to production condition. May incorporate inspection and test requirement into the manufacturing plan. • • Generated Detail Design Specification for the entire process. • • Inspect Cleaning performance over equipment, tools, and manufacturing parts to verify efficiency, and investigates and initiates corrective action of problem and deficiencies to ensure product quality. • • Develops manufacturing processes that are applicable to statistical process control and may develop those technique Ensure process and procedures are in compliance with regulation. • • Responsible for maintaining interdepartmental relationship by coordinating with Operation, Quality, Manufacturing, Validation and Engineering (quality control) department about the scheduling of protocol execution, submission of samples for testing and final report approval. • • Investigated manufacturing challenges and evaluated/implemented process improvement. • • Supported manufacturing facility through the validation of cleaning processes for new manufacturing equipment. • • Involved in selection and determination of Cleaning agents, Surface Area calculations and Acceptance Criteria limits. • • Develop equipment load patterns for equipment washers to clean parts effectively. • • Manage and Coordinate the Validation Master Plan and associated schedule and all related documentation. Required Qualification & Experience: • • Bachelor's Degree: Mechanical Engineering or Bio Medical Engineering or a closely related field. Master's degree a plus. Individual needs to communicate effectively with people in Engineering, Manufacturing, Research and Development, and vendors. Solid technical foundation is critical to success. • • Knowledge of applicable regulatory standards, cGMP and GDP Guidelines. • • Application of knowledge in multiple disciplines, such as Biochemistry, Bio Medical, mechanical engineering etc. • • Documentation skills must be such that logic to the conclusions is easily followed. • • Ability to apply appropriate statistical methods to better understand and improve plant equipment and processes, evaluate new or changed equipment or processes and resolve quality problems.