Ram Subedi Email & Phone Number

One stop for complete environmental monitoring (EM) services for GMP clean rooms.• All EM samples incubated in accordance with US Pharmacopeia guidelines▪ Capacity of incubation: up to 1,500 EM plates• Summary reports available within 24hours of incubation completion.Offering:▪ Routine and dynamic EM sampling, as well as support during EM PQ execution▪ Growth promotion test for culture media▪ Selection of representative colonies on EM plates▪ Microbial identification using third party labs▪ Maintenance of microbial libraries for in-house isolates▪ Routine trending of EM data▪ Quarterly reports for EM programs• Incubation of Biological indicators in validated incubators, up to 2,000 biological indicators▪ Incubation of Media Fill Containers

Providing Commissioning, Qualification and Validation Services. Key skills and characteristics include expertise in the following areas:• Manufacturing Facilities and Utilities• Manufacturing equipment • Packaging and labeling equipment • Laboratory equipment• Computer systems• Building Automation systems • Warehouses• CIP Cycle Development• SIP Cycle Development• Validation Master Plan• Commissioning and Qualification Plan• Project Management

Blue Bell, Pa, Us

Projects: Permanent Intravenous Admixture Unit (P-IVAU) Pharmacy, Center for Cellular Engineering East Terrace Modular Facility and National Cancer Institute TIL Modular Facility at National Institute of Health Bethesda MD. Reviewed and commented on facility specifications and submittals, in preparation for final approvals by client. Generated and executed commissioning checklists and reports for all facility utility systems, including HVAC, Building Automation System, Electrical distribution, Emergency Power, Chilled water, Medical Gases, Telecommunications, Security system etc. using Good Documentation Practices (GDPs).Developed and Performed integrated system testing. This involved testing the interaction and functionality of multiple systems within a facility to ensure that they are operating correctly and in accordance with the design specification. Developed and executed validation protocols including HVAC Cleanrooms, Environmental Monitoring System, Medical Gases, Airflow Visualization ensuring compliance with cGMPs and other regulatory requirements. Investigated and resolved commissioning and validation protocol exceptions / discrepancies.Led CQV meetings and provide update to stakeholders on weekly basis.

Amsterdam, Nl

Walter Reed National Military Medical Center, Silver Spring MDCommissioned Building Automation System (BAS); ensured controls are properly wired and communicating with the BAS, that alarms are generated and trended as required, and that the BAS is operating as per the design specificationDeveloped a detailed plan for testing and validating the performance of the air handling units (AHU’s), Exhaust Fan Units (EFU), Chilled Water System (CHW), Hot Water System (HWS) as well as executed test plan using good documentation practice. Walked down P&ID identifying all of the components of the AHU system, including ductwork, exhaust fans, dampers, and any other relevant components. Developed and Performed integrated system testing. This involves testing the interaction and functionality of multiple systems within a facility to ensure that they are operating correctly and in accordance with the design specification.

Hatboro, Pennsylvania, Us

Novo Nordisk, West Lebanon NHLed and executed Room Qualification on two new manufacturing suites. Tests included: Air Changes, Particulate Count, HEPA Leak, Differential Pressures, and Interlocks testing.Performed thermal mapping of temperature-controlled chambers, warehouses, and SIP (Sterilization-in-Place) on bioreactors.Executed CIP (Clean-in-Place) recipes on upstream and downstream manufacturing equipment without any unplanned intervention.

Glenmark Pharmaceutical, Monroe NCDeveloped and executed an IQ/OQ/PQ protocol for a Nitrogen distribution system and Compressed Air distribution system.Executed IQ/OQ protocols and cleaning/riboflavin studies for a Bin Washer.Executed IQ/OQ/PQ protocols for packaging line equipment including Tablet Counter, Filling Machine, Desiccator, Labeler etc...

Durham, New Hampshire, Us

Undergraduate research was performed at University of New Hampshire which was funded by UNH McNair and National Science Foundation. Our Research was focused on surface chemistry and materials chemistry to develop innovative catalysts for sustainable energy applications in real world. A process of particular interest was solar fuel generation by carbon dioxide reduction on surface catalysts. As a part of undergraduate researcher my focus was to investigate effect of morphology on titanium dioxide photocatalysis. -Competitively selected for funding from McNair scholar program and National Science Foundation -Synthesized nano-particles catalyst with focus on carbon dioxide reduction using photocatalysis-Characterized material using BET, XRD, SEM, and TEM for analysis-Performed Dye-degradation test using different dye-molecules such as Methal-blue to see reactivity -Analyzed inconsistencies and made adjustments to synthesis procedure; tested efficiency of material in its application-Analyzed data using MS Excel-Participated and presented research at University of California Berkeley McNair Symposium 2014 and University of Maryland 2015-Asked to serve as a member of Advisory Committee; provide feedback on research being proposed in order to obtain funding

Scarborough, Maine, Us

-Coordinated with 80 other associates to facilitate best customer service-Provided customers with fast and friendly check out

Bachelor'S Degree, Chemical Engineering

High School Diploma, Chemistry