Ram Subedi

Ram Subedi Email and Phone Number

Commissioning, Qualification and Validation Services, EM Sampling @ Lifecycle Labs
Ram Subedi's Location
Washington DC-Baltimore Area, United States, United States
Ram Subedi's Contact Details

Ram Subedi personal email

n/a
About Ram Subedi

Ram Subedi is a seasoned professional with hands-on experience in commissioning, qualification, and validation of GMP Facilities, Utilities and Equipment in the pharmaceutical and biotech industry . He has a proven track record of successfully leading projects from start to finish, ensuring that all requirements meet or exceed industry standards and regulatory requirements. Extremely passionate about excellence and execution and always strive to approach every task with a right-first-time mentality. Born in a refugee camp in Nepal, Ram faced numerous challenges in his early life, but that never dampened his determination to succeed. He immigrated to the United States in 2009 with a strong desire to better himself and his community. He obtained a degree in Chemical Engineering and immediately began working in the pharmaceutical industry. He is a dedicated and passionate individual who never forgets his humble beginnings and always strives to improve not just for himself but for his community as well. He is known for his ability to appreciate the little things in life and always brings a positive attitude to the workplace.

Ram Subedi's Current Company Details
Lifecycle Labs

Lifecycle Labs

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Commissioning, Qualification and Validation Services, EM Sampling
Ram Subedi Work Experience Details
  • Lifecycle Labs
    Managing Partner
    Lifecycle Labs Oct 2022 - Present
    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
  • Lifecycle Compliance
    Managing Partner
    Lifecycle Compliance Apr 2021 - Present
    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
  • Ips-Integrated Project Services, Llc
    Cqv Project Lead
    Ips-Integrated Project Services, Llc Jun 2019 - Sep 2021
    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.
  • Dps Group Global
    Cqv Engineer
    Dps Group Global Oct 2018 - May 2019
    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.
  • Azzur Group
    Validation Engineer
    Azzur Group Jul 2017 - Oct 2018
    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.
  • Atlantic Technical & Validation Services, Llc
    Validation Engineer
    Atlantic Technical & Validation Services, Llc Jun 2016 - Jun 2017
    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...
  • University Of New Hampshire
    Undergraduate Researcher
    University Of New Hampshire Jun 2014 - May 2015
    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
  • Hannaford Bros. Co.
    Cashier
    Hannaford Bros. Co. Dec 2010 - Jun 2014
    Scarborough, Maine, Us
    -Coordinated with 80 other associates to facilitate best customer service-Provided customers with fast and friendly check out

Ram Subedi Skills

Microsoft Office Microsoft Excel Powerpoint Research Microsoft Word Leadership Teamwork Time Management Customer Service Chemical Engineering Data Analysis Retail Process Engineering Manufacturing Design Of Experiments Inventory Management Strategic Planning Team Leadership Social Media Process Design Uv/vis Event Planning Grocery Matlab Fda Gmp Sem Tga Cashiering Merchandising Inventory Control Loss Prevention Powder X Ray Diffraction Jmp Viscometry Materials Science Tma Public Speaking Teaching Xrd Formulation Chemistry Chemical Formulation Validation

Ram Subedi Education Details

  • University Of New Hampshire
    University Of New Hampshire
    Chemical Engineering
  • Manchester Central High School
    Manchester Central High School
    Chemistry

Frequently Asked Questions about Ram Subedi

What company does Ram Subedi work for?

Ram Subedi works for Lifecycle Labs

What is Ram Subedi's role at the current company?

Ram Subedi's current role is Commissioning, Qualification and Validation Services, EM Sampling.

What is Ram Subedi's email address?

Ram Subedi's email address is ra****@****nds.com

What schools did Ram Subedi attend?

Ram Subedi attended University Of New Hampshire, Manchester Central High School.

What are some of Ram Subedi's interests?

Ram Subedi has interest in Soccer, Manufacturing Engineering, Golf, Children, Sensors, Biotechnology, Environment, Cricket, Science And Technology, Energy.

What skills is Ram Subedi known for?

Ram Subedi has skills like Microsoft Office, Microsoft Excel, Powerpoint, Research, Microsoft Word, Leadership, Teamwork, Time Management, Customer Service, Chemical Engineering, Data Analysis, Retail.

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