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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLEPHONE NUMBER AVAILABLELinkedIn: https://LINKEDIN LINK AVAILABLEEducationMaster of Science: Mechanical Engineering: System Dynamics and Controls August Street Address May 2020California State University, Northridge, CA, USABachelor of Science: Mechanical Engineering August 2013 May 2017Gujarat Technological University, IndiaProfessional ExperiencesSr. Process Validation engineer - Lead Pfizer, Rocky Mount, North Carolina November 2023 PresentResponsibilities:Lead the team of 7 validation engineer to execute equipment validation studies to include protocol preparation, scheduling, execution, including data analyze data and generation of summary reports.Provide high level data analysis support for Quality Investigations.Ensure compliance with latest Pfizer Quality Standards for validation and qualification activities.Schedule and execute validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.Coordination and communication of all testing with affected functional groups and evaluates test results.Assessed potential impact of changes to qualified systems; Identify and implement validation best practices to continuously improve the site validation program.Participated in presentation of results to Regulatory Agency, when necessary.Support regulatory audits through the preparation, defense and interaction with auditors in areas related to sterilization, commodity prep and formulation equipment.Participate in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.Participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).Ensure integration of validation schedule in production schedule for implementation of validation activities and ensure due dates and customer needs are met.Working with PCT Lead, IMEx Deployment Lead, CI Specialists, Tier 1 Element Owners, Operational Excellence and Area Leadership to build, maintain and improve IMEx within the work area.Process Engineer Pfizer, Kalamazoo, Michigan February 2022 October 2023Responsibilities:Executed LNP formulation (SME) and TFF activities for clinical and non-clinical products in GMP Grade C/D manufacturing suites.Collaborated with other Pfizer site to optimize ChargePoint operation for LIPID and Buffer dispensing.Standardized batch record tracking system resulted in 90% reduction in duplicate documentation and printing of incorrect version.Reduced 5% Human error by Planning and Organizing training session and training material for technicians and new hires.Wrote new process batch records according to Pfizer PHP guidelines which minimized 80% on the floor human errors.Collected/compared process parameters data from PI vision and Historian graphs to understand abnormal changes and avoid process delays.Supported technical and process related issues and provided troubleshooting expertise which brought 30% reduction in downtime.Completed RIBOFLAVIN TESTING and Spray Ball Modification project before the deadline for all the suite saved 5 days of project timeline.Participated in multiple quality and safety investigations to identify route cause and develop mitigation strategies.Received trainers training for IIF (incident and injury free) Pfizer and trained colleagues and contractors which developed safety culture and reduction in injuries.Assisted Micro and CV for collecting swabbing data to validate commercial production.Reduced CIP time to 11 hours from 14 hours by implementing process parameters.Provided on and off shift support and expertise for all the areas 24/7 to keep the manpower green for PPQs and IPRs.Helped Automation to run process VTs and troubleshoot process related automation issues by identifying 15% of recipe error and alarm processing.Improvised in process Micro and DPMT samples delivery system that eliminated missing and lost samples by 75%.Manufacturing Process Engineer Amgen, Thousand Oaks, California February 2021 February 2022Responsibilities:Executed product filling and formulation activities for clinical and non-clinical products in GMP ISO Grade 5/7/8 manufacturing facility.Led the team of 12 engineers to implement 3rd generation filling line and vial washer.Performed data analysis of critical process parameters for Process Development and Engineering teams for stopper installation resulted in 60% error reduction.Successfully and safely Performed and executed Media fill for all the new drug products with different size of vialsImproved and Performed Filter integrity and glove integrity test before and after the process to collect the data for process improvements.Initiated and completed six sigma yellow belt project to reduce the stopper height error for syringe filling line resulted in 89% accuracy.Recognized, reported, and troubleshot filling equipment for nested syringe line failures to reduce the downtime during the production.Supported new product introduction technologies (3rd generation filling line) into the facility by leading the team of 6 engineering technicians.Perform initial review of manufacturing batch record and batch end report after production to reduce documentation error by 80%.Led 5 quality root cause analysis and process related change control to reduce the process error by 18%.Create or revise standard operating procedure and electronic batch records according to the site policies and FDA guidelines.Utilize appropriate system for job duties like SAP, LIMS, QTS, eQMS.Provided on hand support for weight calibration, WFI supply, PLC troubleshoot with maintenance to expedite the process by 10%.Worked on commissioning of DCS, ensuring seamless integration and functionality.Designed and Implemented SCADA system, control and alarm response for vial platform and utilities.Developed and executed commissioning plan.Manufacturing Process Engineer Honda of America Mfg. Inc., Ohio August 2020 January 2021Responsibilities:Ensured optimized production of Honda CR-V, Acura MDX and Acura RDX.Led the team of 7 engineers in the design and implementation of automated production system with increase in 45% efficiency.Setup and operate all production equipment in accordance with current good manufacturing practices and standard operating proceduresProgrammed and debugged Allen Bradly PLCs for seamless integration with production processes, reducing downtime by 4%.Collaborated with R&D engineers to prototype and test automation technologies for welding and painting.Modified Bill of Materials, drawings, and specifications as per automation requirements.Designed and implemented machine vision systems for quality control resulting in 10% reduction in defects and warranty claims.Assisted in installation, calibration, maintenance of automated production equipment, ensuring optimal performance and uptime.Implemented 6S visual management and standard work for tailgate assembly line.Inspected over 300 cars for quality and adherence to customer satisfaction per day.Performed Quality measurement including CMM, Profile, Roundness, surface finish and torque.Manufacturing Engineer & PCB Design Editor CASCO Circuits, INC., Chatsworth, CAMay 2018 - July 2020Responsibilities:Built prototype of PCB from hand sketches and drawings using AUTOCAD and SOLIDWORKS.Conducted FMEA for PCB manufacturing and testing generating annual cost-saving of $5000.Evaluated procurement strategies through re-assessing raw material and parts vendors to obtain best quotes.Ensured available up-time for all process equipment met minimum processing time requirements defined by the production plan.Provided the quality organization with technical resources to support corrective actions, root-cause determination, problems and inquires.Participated in facility safety audits and ensured the safe design of all equipment.Created electrical test net list programs and fixtures for two-sided board testing apparatus using CAM350 and AutoCAD.Wrote program for PCB drilling and routing using CNC Excelling Mark V machine.Prepared complex PCBS assemblies with detailed copper traces and electrical component locations using PRO/ENGINEER.Generated 2D fabrication drawing and 3D modeling using AutoCAD for PCB manufacturing with the help of ECAD and MCAD.Engineering ProjectsAutonomous Intelligent Vehicle California State University, Northridge, USA November -2018Developed a LABVIEW syntax and created a prototype of four-wheeled autonomous intelligent vehicle which can go to desired location with pinpoint accuracy without any failure.Design, modeling, and simulation of vane-less ion wind generator GTU, India May-2017The design optimization was driven by both experimental testing and FMEA simulation in SOLIDWORS 2016. |
