Nadeem Mohammad Email & Phone Number

Providence, Rhode Island, United States

• Developed and executed IOQ protocols of process equipment for cell therapy manufacturing.
• Developed and Executed Commissioning protocols for Custom-made system for Process Development non-GMP equipment.
• Developed and Executed IOQ for Custom-made systems for manufacturing, AD and QC.
• Developed and executed decommissioning protocols for custom made manufacturing equipment.
• Developed and Executed IOQ, RQ protocols for Supply chain refrigerators using Ellab Dataloggers.
• Authored life cycle documents and RTM for non-GxP equipment and GxP equipment.

Framingham, Massachusetts, United States

• Developed and executed IOQ protocols of process equipment for cell therapy manufacturing.
• Developed and Executed Commissioning protocols for Custom-made system for Process Development non-GMP equipment like tensile tester, Keyence CMM, Heating magnetic stir, Orbitals and Incubator shakers.
• Developed and Executed IOQ for Custom-made systems for manufacturing, AD and QC.
• Developed and executed decommissioning protocols for custom made manufacturing equipment.
• Developed and Executed IOQ, RQ protocols for Supply chain refrigerators using Ellab Dataloggers.
• Authored life cycle documents and RTM for non-GxP equipment and GxP equipment.

• Managed Validation Lifecycle for business including Change Control relating to Process, Equipment, Materials, etc.
• Worked on developing and executing DQ’s, CM, and IOQ protocols for Water systems, HVAC Clean air, Nitrogen and CIP systems.
• Developed System Impact Assessments of process equipment filtration system (final filtration, depth filtration, ultra-filtration), temperature control units, portable tanks, freezers etc.
• Worked on developing and executing DQ, CM, and OQ protocols for Portable Bioreactor Vessels.
• Worked on commissioning and qualification with external vendors for commissioning of steam sterilizers, Dry heat sterilizers, Tunnel, vial washing systems, CIP Systems, SIP.
• Experience in developing cleaning methods and validation test methods for CIP Skids.

Massachusetts, United States

• Performed temperature mapping studies using Kaye Validator AVS, Kaye ValProbe and E-ValPro dataloggers.
• Collected and analyzed user requirements and detailed design specifications, functional requirement specifications to develop VMP, SAT, IOQ’s and risk analysis.
• Development and execution of validation change control documents, Reviewing and documenting electronic Audit trails, retention period, ERES, data backup and data recovery.
• Worked with equipment vendors to collect equipment manual and other required documents.
• Involved in cycle development of VHP cycle as part of qualification verified the following parameters like unidirectional airflow within the unit, differential pressure, temperature, relative humidity, aeration phase.
• Authored documents independently such as Validation Master Plan (VMP), Site Acceptance Testing (SAT), Installation and Operational Qualification (IOQ) and final reports for tanks, spray dryer and isolator.

Department Of Mechanical And Aerospace Engineering

• Designed and fabricated single and bi-material test specimen of PLA, ABS, ASA, TPU and PC-ABS
• Examined the surface topography using Scanning Electron Microscopy (SEM) and ImageJ analysis for microstructural characterization
• Performed heat treatments, tensile test and compression test for material characterization

Old Dominion University, Norfolk

• Designed and fabricated single and bi-material test using Stratasys f370, Lulzbot Taz Pro and Lulzbot Taz6
• Analyzed the structural composition of specimens using SEM and ImageJ
• Performed tensile test and compressive test for material characterization using MTS universal testing machine
• Enhanced the material properties of 3D printed materials by annealing resulting in 51% increase of avg compressive peak strength
• Designed various prototypes and test specimens for 3D printing using SolidWorks for research in the Mechanical and Aerospace department

Old Domininon University, Norfolk

• Trained undergrad students on TRACE 700 software for design of building energy system using the concepts of HVAC
• Mentored undergrad students on a project to design the energy system in the Kaufman building at Old Dominion University to the old modify HVAC system
• Graded Assignment of Environment controls course

Old Dominion University, Norfolk

• Assisted students with their course related problems for the courses: Engineering Mechanics, Solid mechanics, FEA, Aerospace structures, Kinematics, Dynamics and Environmental controls, Autodesk inventor

Old Dominion University, Norfolk

• Developed salary equity sheets using MS-Excel and generated statistical reports using XLSTAT in interpreting salary trends of more than 2500 employees at ODU using data computation and market research analysis.
• Maintained training courses and organization modules (Automatic Thinking, Search Committee Training, Sexual Harassment Training) on the blackboard for full-time employees at ODU.
• Maintained data integrity and accuracy for various projects including salary equity review, tracked and analyzed employee enrollment & training verification.

Master'S Degree, Mechanical And Aerospace Engineering

Bachelor Of Technology - Btech, Aeronautical Engineering