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.• Developed Periodic Assessments for Custom equipment to determine qualified state by evaluating Change Controls and Deviations from Electronic document management system (Veeva), Maintenance and Calibration records from Computerized Maintenance management (Nuvolo), Performance trends, Qualification requirements, Operation procedures and Visual inspections.• Developed and executed IOQ wrapper protocols of off-the-shelf equipment.• Developed and Executed Commissioning protocols for Fume hoods.• Worked on Veeva (EDMS) to approve and review Life cycle documents, IOPQ Protocols, RTMs, Vendor protocols, Executed protocols, Validation Summary reports.• Involved in Sampling of Parts washer for Rinse water samples, Swab samples and Placebo samples during parts washer cleaning validation protocol execution.• Prepared written validation reports with high level of detail and organization, communicate with project stakeholders the progress relative to plan.• Developed and completed deliverables related to CQV activities as needed to ensure objectives are met.• Validated equipment by following keys elements of data integrity (ALCOA, ALCOA++).

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.• Developed Periodic Assessments for Custom equipment to determine qualified state by evaluating Change Controls and Deviations from Electronic document management system (Veeva), Maintenance and Calibration records from Computerized Maintenance management (Nuvolo), Performance trends, Qualification requirements, Operation procedures and Visual inspections.• Developed and executed IOQ wrapper protocols of off-the-shelf equipment.• Developed and Executed Commissioning protocols for Fume hoods.• Worked on Veeva (EDMS) to approve and review Life cycle documents, IOPQ Protocols, RTMs, Vendor protocols, Executed protocols, Validation Summary reports.• Involved in Sampling of Parts washer for Rinse water samples, Swab samples and Placebo samples during parts washer cleaning validation protocol execution.• Prepared written validation reports with high level of detail and organization, communicate with project stakeholders the progress relative to plan.• Developed and completed deliverables related to CQV activities as needed to ensure objectives are met.• Validated equipment by following keys elements of data integrity (ALCOA, ALCOA++).• Ensured secure access controls for systems handling critical data and collaborated with cross functional teams to maintain data integrity.

• 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.• Performed IQ, OQ, PQ of Refrigerators, coolers, freezers, flow hoods, BSC, incubators, mixers.• Worked on SIP validation of bioreactors, filtration systems and Lyophilizer (Cycle development, Temperature mapping and BI evaluation, and SAL calculations).• Involved in validating Process Equipment, Procedures and Systems, and assisting the project manager in supervising the manufacturing operations.• Performed riboflavin spray ball coverage testing for washers, tanks, fermenters.• Involved in execution of IQ and OQ protocols on HVAC and Compressed air utilities qualification.• Conducted smoke studies to study the air flow pattern for BSCs (Biosafety Cabinets) and Laminar Airflow Pass Throughs.• Performed qualification process for vaporized hydrogen peroxide (VHP) cycle for isolator. • Sterilization in Place (SIP) system and Controlled temperature units (CTU’s) like coolers, freezers, incubators, incubator shakers, Environmental chambers along with autoclaves and lyophilizer.• Qualified SIP process for tanks, fermenters using Kaye validator and biological indicators.

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 (residual h2o2 concentration), process h2o3 concentration, air particles counts.• 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.• Developed Clean-in-place (CIP)/ Sterilization-in-place (SIP) cycle development, spray coverage testing, sample testing and parameter calculation for CIP skid, TFF skid, spray dryer, tanks and isolators.• Developed IQ, OQ, and PQ of fully automated CIP skids for cleaning of all types of equipment; Spray dryer, tanks and TFF skid, Involved in qualification of the Grade C and D facility.• Worked on developing IOQ, PQ for Heat Sealers, Autoclaves, Isolator, CIP skids, Laboratory washers, Serialization, Check-weigher, Refrigerators, Incubators.• Performed temperature mapping, thermocouple calibration, sterilization, heat distribution, penetration, three biological indicator studies for various process equipment’s.• Drafted standard operating procedures (SOPs) and supported QA audits of existing operating procedures to ensure compliance with company current regulatory requirements.

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