Resourceful Compliance and Quality Validation Engineer well-versed in producing strong test cases and scripts for manual and automated systems. Skillful in training, evaluating performance and improving procedures.
Dedicated and innovative graduate chemical engineer and physical scientist with proven success in molecular science and nanotechnology research.
Formulation, Product Development, Research and Development, Batch Operations, Equipment Design, Equipment Inspection and Performance/Quality Checks, Process Development
C/C++, AutoCAD, MS Office Suite, Scanning Electron Microscopy, EDS, X-ray Diffraction (XRD), XRF Analysis, Ultrafiltration and Diafiltration Techniques, Ultraviolet Spectrometry, LC & GC Chromatography, HPLC, FTIR, Computational Monte-Carlo Simulation, COMSOL.
Company Name | City, StateCompliance and Quality Engineer01/2021 - Current
Documented entire validation process and recorded all changes for pharmaceutical drug manufacturing and laboratory equipment, including but not limited to HEPA filters, controlled temperature units, and packaging line equipment. .
Implemented OSHA compliance quality and safety plans.
Worked closely with team members to deliver project requirements, develop solutions and meet deadlines.
Author Validation and Production environment computer system User and Functional requirements, Validation Plan, Data Migration Plan, IQ/OQ protocols, UAT test scripts, Summary reports, Configuration Memos.
Develop test strategies and support computer system validation projects subject to health authority electronic record and signature requirements, including FDA's 21 CFR Part 11 and EMA's Annex 11.
Partake in vendor Factory Acceptance Testing and Site Acceptance Testing.
Generate and execute temperature mapping protocols for cold rooms and freezers.
Worked with Agile and Scrum methodologies to accomplish project milestones and meet demanding timelines.
Company Name | City, StateValidation Engineer02/2019 - 01/2021
Support validation of all the Computer Systems according to the FDA, GxP regulations, Evonik policies/ procedures, GAMP5 best practices and 21 CFR Part 11 regulations.
Develop, manage, and author GxP system lifecycle documents, including Validation Plans, User Requirement Specification, Functional and Design Specification, Test Protocols, User Acceptance Testing, Traceability Matrix, Validation Reports, System Administrative Manual, System Overview for the Reactors, Dryers, and Water Purification System.
Avails Share-Point for the Protocol and issue tracker and follow the GAMP5 best practices.
Provide oversight, managed and coordinated various vendor activities including Installation and Operation (IOQ) qualifications, Vendor audits and reports.
Company Name | City, StateValidation Engineer06/2017 - 02/2019
Responsible for validating tablet hardness tester, its respective software and formed standard operating procedure for the same. Created recipes for distinct size, shape and hardness of tablets.
Involved in temperature mapping project and installation of environmental monitoring system so that the required temperature is maintained in packaging and end-packaging lines.
Assigned CAPAs using Integrated Documentation Management system, to deal with deviations occurring in process, equipment, packaging lines.
Determined Critical Process Parameters (CPP), Critical Quality Attributes (CQA) for packaging lines and equipment for safe operations and successful distribution testing.
Performed gap analysis to compare installation/operational/performance qualification and user requirement specification (URS) as well as factory acceptance test (FAT).
Associated with the team in forming the preventative maintenance procedure, periodic review cycle, risk impact determination following GDP/GMP.
Assisted project manager in managing and completing product reviews, risk assessment, calibration standard operating procedure (SOP), system registry (SR) with the help of centralized technical documentation management system (TDMS) for AstraZenca .
Company Name | City, StateGraduate Research Assistant09/2013 - 08/2016
Performed computational research on phonon propagation in a diamond with imperfect internal structure using Monte Carlo simulation. Applied C++ to simulate thermal conductivities in diamonds in scales ranging from macro to nano.
Researched the synthesis and transport properties of copper based nanowires. Synthesized copper nanowires on an aluminum template using electrochemical techniques. Analyzed the density, direction of growth and quality of copper-based nanowires in a conductive solution using scanning electron microscopy.
Company Name | City, StateChemical Engineering Intern12/2012 - 04/2013
Monitored and supervised batch product manufacturing of phenol free thermal paper color developer, pesol, and polyurethane. Performed quality control tests on paper dyes using rotational viscometer and stripping process on Pesol. Prepared detailed documentation on all aspects of training period covering manufacturing procedures, mass and energy balance, designs, safety measures, and cost estimation for establishing processes.
Prepared detailed documentation on all aspects of training period including coverage of manufacturing procedures, mass and energy balance, equipment designs, safety measures, and cost estimation for establishing manufacturing processes.
Education and Training
Louisiana Tech University | City, StateMaster of Science in Molecular Science And Nanotechnology08/2016
Dharmsinh Desai University | CityBachelor of Technology in Chemical Engineering05/2013
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Master of Science in Molecular Science And Nanotechnology Bachelor of Technology in Chemical Engineering
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