▪ Responsible for upkeep and maintenance of three main business software programs:o Temperature monitoring software for warehouse business unit.o Training and document management software for three business units.o Warehouse management system (audit role) for the warehouse business unit.▪ Ensure data is organized, safe and available in paper form, electronic files, or database form. ▪ Generate documentation to assure compliance with GMP and Specifications. ▪ Support established work priorities to meet targets and timelines.▪ Develop and revise applicable SOPs. ▪ Provide QA oversight and review during the validation process. ▪ Manage administrative documents including binder documents and fulfill client document requests.▪ Manage mailing and shipping requests.▪ Manage electronic files on the company server.▪ Manage field equipment tracking.▪ Event planning and industry affiliation enrollment.

• Developed, reviewed, and executeed validation protocols (IQ, OQ, and PQ) for facilities/utilities (HVAC, process gas systems), equipment (automated, manufacturing, and laboratory), and computerized system (BMS, CMMS/RAM) of new and existing GMP manufacturing facilities following ISPE GEP and GDP guidelines at Nitto Denko Avecia, Repligen, and Histogenics• Designed user requirements and functionality requirements for enterprise level software for use in regulated environments to be compliant with 21 CFR Part 11 and ISPE GAMP 5.• Performed environmental monitoring and compressed gas sampling to meet ISO 14644 cleanroom standards • Reviewed construction documents and perform walk downs of piping and instrumentation diagrams• Development and redline/review of standard operating procedures (SOPs) for GMP processes, systems and equipment.

• Performed data entry and maintenance of computerized asset management system for a new GMP drug manufacturing facility at Moderna Therapeutics• Developed asset structure and hierarchy for hundreds of new system assets• Processed calibration and maintenance activities and the administration of the CMMS software

• Developed, reviewed, and executed validation protocols (IQ, OQ, and PQ) for HVAC, automated equipment, and computerized building management system of a new GMP manufacturing facility following ISPE GEP and GDP guidelines at Nitto Denko Avecia• Performed environmental monitoring to meet ISO 14644 cleanroom standards • Reviewed construction documents and performed walk downs of piping and instrumentation diagrams• Developed and redlined/reviewed standard operating procedures (SOPs) for GMP processes, systems and equipment.

• Managed engineering documentation for the new Vertex Boston headquarters.• Assisted in the operational process improvement efforts for the new Vertex headquarters.• Developed and executed commissioning and validation protocols for GMP systems including air handlers, chillers, automated pumps and valves, sensors, programmable logic controllers, and computerized management systems• Developed standard operating procedures and work instructions following ISPE GEP guidelines• Reviewed construction documents and perform drawing walk downs to align with engineering specifications• Worked with vendors and contractors for the design and installation of systems and components• Performed temperature mappings of warehouse spaces to verify integrity of HVAC systems

• Set up and performed various tests on mechanical seals and packing.• Worked with high pressure and high temperature systems using hazardous gases and fluids.• Collected test data and examined material wear to write analysis reports and design recommendations.• Maintained lab cleanliness and organization of tools and materials.

• Worked with meter shop technicians and equipment to improve shop efficiency.• Compiled data from customer locations to ensure pipe conditions are in compliance with regulations.• Learned the operations of liquid natural gas supply, service, and distribution networks.• Analyzed safety incident data and created improved procedures for field and shop workers.• Conducted intensive site and equipment inspections in the field and the shop.• Coordinate with equipment vendors to improve worker safety and efficiency.• Managed and documented multiple projects while meeting short lead times.

• Developed drafted diagrams, detail drawings, equipment arrangement and instrumentation plans• Conducted hydraulic system calculations to optimize piping arrangement• Assisted with project coordination and documentation• Drafted plans and details for the first rare earth metal mining facility in the United States• Worked on cogeneration plants for sites such as the campuses of MIT, NYU, and UMASS Amherst• Project Phoenix: First rare earth metal mining facility in the United States.

• Monitor and maintain various student computer labs.• Troubleshoot computer and printer issues.• Assist students with PC-related problems.