Bindu Susmitha Adapa

About Bindu Susmitha Adapa

An enthusiastic and thorough Biomedical Engineer with 5 years of varied experience, and an inherent capacity to combine a high degree of technical knowledge with creativity-FDA regulated environment with good understanding of 21 CFR part 11, part 50, part 56, part58, part 210, part 211, part 820, part 825, ISO 13485, 14971, cGxP (GMP, GDP, GCP and GLP), Risk Assessment, FMEA, CAPA, Change control, GAP Analysis, RTM-Performed Validation for several manufacturing and lab equipment in compliance with cGMP and 21 CFR Part11-Performed change control qualifications, investigations and root cause analysis for discrepancies during the validation. Raised Non-conformances and performed Corrective and Preventive Actions (CAPA)-Performed data acquisition of an electrical current and voltage output from biosensor using sophisticated multi-channel data chips, instruments like Nano voltmeters and LabView Signal Express-Conducted temperature mapping studies on various process equipment using Kaye Validator System and Wireless Data Logger’s; and generated reports for Statistical analysis and Lethality calculations-Proficient in generating documentation for IQ/OQ/PQ Protocols, UFRS, Validation Final Reports, Technical Reports, Standard Operating Procedures and Interim Summary Reports as well as in qualifying the Manufacturing and Lab equipment-Carried out retrospective validations, concurrent validations, annual validations and re-validations-Built a prototype and successfully designed a Biosensor Based Wheelchair-Developed a highly sensitive micro-fluidic biosensor for detecting very small voltage signals ranging from nV to µV, and for measuring dynamic temperature changes-Improved the design of the microfluidic device, hardware set up, output electrical signal, noise reduction and the in-flow injection system-Worked extensively on Building Prototypes, Testing, Validation, Data Analysis, Maintenance, Documentation, Report Generation and Training.

Experience

1. Product Transfer Lead

   Merck

   Jun 2022 — Present · Omaha, NE, US

Education

• JB Institute Of Engineering and Technology (JBIET)

  Bachelor of Technology (B.Tech.), Bio-Medical Engineering

  2006 — 2010

• Louisiana Tech University

  Master of Science (M.S.), Bio-Medical Engineer

  2011 — 2014

Skills

• Change Management
• U.s. Title 21 Cfr Part 11 Regulation
• Biomaterials
• Iso 14971
• Life Sciences
• Calibration
• Biosensors
• Iso 13485
• Microfluidics
• Labview
• Quality System
• V&V
• Design of Experiments
• Manufacturing
• Powerpoint
• Microsoft Excel
• U.s. Food and Drug Administration (Fda)
• Standard Operating Procedure (Sop)
• Calorimeter
• Cleaning Validation
• Testing
• Process Validation
• Cgmp Manufacturing
• Pharmaceutical Industry
• Sop
• Fda
• Quality Control
• Gmp
• Nanofabrication
• Validation
• Fmea
• 21 Cfr Part 11
• Corrective and Preventive Action (Capa)
• Equipment Validation
• Biomedical Engineering
• Metal Fabrication
• Biomedical Device Design
• Research
• Change Control
• Data Analysis