Sameer N Email & Phone Number

• A Validation Engineer experienced in Commissioning & Qualification of laboratory and manufacturing equipment, Process Validation, Quality assurance, In compliance with FDA regulations (21 CFR Part11, part210, part211, part820) and ISO standards (ISO13485 and ISO9001) in Medical Device and Pharmaceutical Industry.• Extensive experience in technical writing of validation protocols (Computer System Validation CSV, Cleaning validation, CIP, Sterilize IN Place SIP, Design Qualification, Site Acceptance Tests SAT’s, Factory Acceptance Tests FAT’s, facility and Utility qualification, Validation Master Plans, Requirement Traceability Matrix) in accordance with FDA regulations.• Developed together with other stakeholders the change scope and strategy to execute the change in a cGMP environment, process equipment, utilities, facility modification requirements to meet regulatory expectations and client quality standards for aseptic production environment.• Experience in the preparation of sequence of operations for HVAC and control systems and able to perform point-to-point commissioning of Energy Management Systems (EMS).• Performed Operation Qualification using thermocouple calibration and Temperature mapping of equipment like autoclaves, TOC, incubators, freezers, refrigerators, ovens.• Experience with cleaning cycles of variety of equipment including process vessels, packaging equipment, parts washers, and production facilities.• Managed and developed processes and technologies such as lyophilization, clean in place (CIP) / sterilize in place (SIP), water systems, waste systems, and utility systems.• Developed detailed Project Plan, reviewed User Requirement Specifications (URS) and Functional Requirements Specifications (FRS)• Experienced in developing Corrective and Preventive Actions (CAPA), Non-Conformances (NC) and highlighting and suggesting their mediation plans to mitigate the non-compliance.• Authored cGMP risk assessments, user requirements• Authored and executed Commissioning Test Plan (CTP), Installation/ Operational Qualification (IOQ), Performance Qualification (PQ) for the Sterilization Systems•• Strong understanding and working experience with cGxP (GMP, GDP, GLP, and GAMP) standards• In depth knowledge in 21 CFR, Part 11 Compliance, a strong base in Process Validation, Complaint Handling, Test method validation and Equipment Qualification. • Knowledge of design engineering, particularly in aseptic processing, fluid dynamics, heat transfer, sanitary piping practices and process/instrumentation diagrams.

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  Wichita State University

  Industrial Engineering