Saiganesh Reddy

About Saiganesh Reddy

As Cleaning validation engineering experience across pharmaceutical, medical device, and…

Experience

1. Product Development Engineer

   Alcon

   Nov 2024 — Present · Houston, TX, US

   Actively participate in design and development activities for a variety of drug delivery products in a design control environment.• Experienced in design & development of Combinational Medical Device Products Combinational Drug Delivery and Consumables sets of Infusion pump, Patch Pumps, Auto injectors.• Supported design control and design transfer activities for product development efforts. Supported product development and design through verification and validation activities• Worked with Product Combination teams (IQ, OQ, and PQ) of Equipment, facility, and combination drug (drug delivery system using medical device)• Developed and performed process validation (IQ, OQ, PQ), design validation, and design verification.• Perform Validation and Verification Activities for Medical Devices-Performed assessments on previously validated process validation documents• Involved in development of combination product risk management files e.g. Task Analysis-Use Error Analysis, dFMEA, pFMEA, Device Risk Management Plan and Reports• Performed mechanical and container closure integrity testing on combination products with various instruments in labs which are FDA registered, cGMP compliant, and ISO/IEC 17025:2017 Accredited.• Subject matter expertise in packaging engineering or device/combination product assembly experience working in GMP (Good Manufacturing Practices) and GDP (Good Document Practices)• Perform design verification/ validation and process capability studies for products.• Worked on Test Method Validations (TMV) to support Design Verification testing, developing and validating test methods for in-process and final inspections and Statistical Process Controls (SPC)• Facilitated multiple product development process, design validation, design verification, test plan, process validation, substantiation, implementation and customer acceptance of mechanical designs for product improvements to increase product reliability, development process.•

Education

• Webster University

  Master of Science (M.S.)

• Bharath Institute Of Science And Technology

  Bachelor's degree