Sahil Joshi Email & Phone Number

El Segundo, California, United States

Implemented comprehensive procedural and equipment strategies for fully aseptic manufacturing processing. Enhanced productivity, regulatory compliance, and reliability by improving cell-culture and aseptic filling manufacturing processes for clinical bladder, lung, and pancreatic cancer, COVID-19, and HIV therapeutics Engineering and Manufacturing Subject Matter Expert (SME) for critical equipment including Robotic Aseptic Filling Machine, Small and Large Scale Cell Culture Bioreactors, Utility Systems, HVAC, Filtration, and Autoclaves Responsible for the design and implementation of large scale capital projects for multiple manufacturing facilities: Designed and constructed a $50M GMP biotech process development and manufacturing facility, upgraded and expanded as well as integrated new process development methodologies into existing facilities per business needsManaged engineers and directed a team of engineering consultants, ensuring successful project management and project delivery for both small and large-scale capital initiatives across seven GMP manufacturing facilities Supervised metrology and maintenance programs, including developing and implementing asset management programs and calibration and maintenance procedures, to ensure regulatory compliance and equipment reliabilityInterfaced with FDA and California Health Department auditors as the engineering SME for company audits.Executed Factory Acceptance Tests (FATs) of critical process equipment valued from $1M and $15M, including an automatic aseptic vial filling line with lyophilizers as well as an automatic inspection and labeling machine

El Segundo, California, United States

Conducted deviation investigations for process equipment, implemented Corrective and Preventive Actions (CAPA), and executed Change Controls to ensure compliance with change management standards set by the FDAFostered cross-functional collaboration with departments including Validation, Process Science, Quality Assurance, Manufacturing, Facilities, Quality Engineering, and Quality Control Microbiology, alongside executive leadership, to effectively troubleshoot project challenges utilizing analytical problem-solving expertise Interfaced with multiple vendors of process equipment, facility systems, and utility systems to ensure reliability and high performance in order to meet the required FDA and regulatory compliance guidelines and standards

La Verne

Validation Engineer• Executed Installation, Controller, and Operational Qualifications on the newly installed Sterile Filtration System• Performed SIP and CIP Cycle Developments and Performance Qualifications for the Sterile Filtration System. Tested to fine-tune the desired manufacturing parameters as well as to ensure cycles met approved Gilead QC standards. Performed temperature mapping utilizing biological indicators for SIP testing. • Wrote and executed in-depth validation qualification (IQ, OQ, PQ, etc), performance validation (PV), and Media-Fill protocols as well as developed associated final reports.• Worked with Engineering, Manufacturing, and Automation to initiate and complete change controls• Revised system lifecycle documents (URS, FDS, SDS, SOP, etc) per results of qualificationsCommissioning Team Lead • Managed Vial Fill Line commissioning team for a new greenfield GMP facility. Coordinated with Management, Validation, Automation, SMEs, Engineering, and Construction to ensure complete commissioning of each system.• Wrote and executed in-depth commissioning protocols and summary reports. • Verified system P&IDs, URSs, FSs, and TOPs during commissioning process. Assisted in investigation and resolution of deviations encountered during execution. • Performed extensive temperature mapping on the Depyrogenation Tunnel and Lyophilizer (Freeze Dryer)• Witnessed FATs, SATs, and vendor start-up and testing. • Systems Commissioned:o Process Equipment: Vial Fill Line (Internal Vial Washer, Depyrogenation Tunnel, Vial Filler, Automatic Loading and Unloading System, Lyophilizer, Vial Capper, and External Vial Washer)o GMP Utility Systems: Feed Water Generation and Distribution and GMP Air Handler Unitso Non-GMP Utility Systems: Plant Steam, Heating Hot Water, Laboratory Gases, Solvent Emissions Reduction System, Process Waste Water and more

Pomona

• Prepared temperature calibration testing using Kaye Validators and Intelligent Resistant Temperature Devices (IRTDs)• Worked with the metrology department to help with the loaning out or repair of calibration equipment• Performed comprehensive temperature mapping of a client’s warehouse using calibrated temperature data loggers• Assisted the software validation team in data migration to a new version of ACE, PSC’s compliance and validation software • Developed a migration script and deliverables for the transfer of information and metadata to the new version of the ACE software• Performed dry runs on test scripts to validate the performance and viability of different functions of the ACE software

Santa Ana, Ca

Behr Process Corporation is one of the premier manufactures of quality paints. Responsible for creating and testing R&D formulas:Created new paints based off a self-created formula. Improved previous formulas by adding or subtracting different chemicals using different statistical analytics from the data retrieved from testingAnalyzed the created paint using a multitude of testing methods and specialized testing equipmentPrepared test reports and presented results to R&D management team

Rancho Bernardo, Ca

Hewlett Packard is a leading worldwide provider of products, technologies, software, solutions and services. Responsible for ink testing for a new CAD printer as part of HPs writing systems division of Imaging and Printing Systems:Coded and tested new plot files to identify the ideal settings and configurations for each different media set by utilizing sensitive experimental test-beds to retrieve data sets for a new ink-jet CAD single pass printer. Utilized design of experiment methodology to develop optimal parameters to identify media compatibility with the printerCollected and analyzed qualitative and quantitative data sets using statistical data analyticsPresented final report to local and international R & D leadership team

Anaheim Ca

Brandify is a locator-based company that develops local search marketing solutions that enable businesses to establish customer relationships. Responsible for providing support to client services, project management, and sales and marketing: Participated in developing multiple proposals for Fortune 500 companies. Presented draft proposals to the CEO and VP of sales and marketingHelped to create a pricing tool for product management and marketing organization

Scottsdale, Az

Co-authored a published research paper in the American Journal of Roentgenology with a leading research radiologistCollected extensive data on more than 1500 patients to investigate the predictors of bleeding during thoracentesis

Bachelor Of Science (Bs), Chemical Engineering

Activities and Societies: American Institute of Chemical Engineering

High School Diploma