Engineer Engineering

DIVYESHKUMAR PATEL

Email: ***************@*****.***

Phone No: 732-***-****

CAREER PROFILE:

• 4+ years of experience in pharmaceutical and mechanical industry with hands on experience in equipment procurement and Qualification, new GMP facility readiness. Qualification related to topical cream/ointment and liquid manufacturing and packaging.

• Highly experienced in managing a team of validation engineers.

• Proficient in managing qualification projects for equipment, facility & utility.

• Experienced in ensuring proper cGMP and safety requirements are followed to meet Quality Assurance requirements as per FDA guidelines.

• Extensive knowledge in handling change control forms & SOP’s through QUMAS.

• Having exceptional team leading skills, considering employee development to be a major factor for personal development. Highly motivated with positive attitude towards executing new ideas and learning new dosage forms. PROFESSIONAL EXPERIENCE:

Validation Engineer, Techno Pro Solutions, NJ, USA (May 2018 – Present)

• Good knowledge of 21 CFR Part11, Predicate Rule, concept of validation.

• Created and executed the qualification protocols for production equipment. Developing and executing the Installation Qualification, Operational Qualification and Performance Qualification of production equipment’s related to Topical and liquid manufacturing.

• Performed facility and utility qualification, which includes developing and executing the IQ/OQ/PQ for Purified Water System, Compressed Air Systems, Nitrogen System, HVAC System and Area Qualification.

• Qualification of stability chambers to accommodate stability sample storage.

• Responsible for the design and Installation of packaging equipment with track and trace system.

• Development, review and execution of qualification protocols for Unscrambler, Tablet Counter, desiccant Inserter, Cottoner, Capper, Induction Sealer, Labeler, Topsert and Track and Trace system which consist of Label vision system, 360 verification system, Collection and Pallet label system.

• Work collaboratively with Quality/Production/R&D team to avoid production/ANDA interruption from Engineering and qualification perspective.

• Participate in site acceptance test (SAT) and factory acceptance test (FAT) executions during procurement of new equipment’s.

• Generate URS for required equipment’s as per R&D and operation department requirements.

• Created Standard Operation Procedures (SOP) for Setup, operation and Preventive maintenance of production equipment’s and facility utilities.

• Weekly temperature and humidity monitoring of production rooms, cold storage area, warehouse and retain sample rooms using Testo and Vaisala data loggers.

• Daily activity also includes acquiring quotation form different vendors and issuing purchase orders for required parts.

• Regular monitoring and tracking of calibration reports for all equipment’s and HEPA filter certification, performing calibration before its due date.

• Use Kaye Validator to perform study on Thermal mapping of Walk-in refrigerator

• HEPA testing, HEPA Bank Testing, (CFM) Air flow Measurement, Particle Count test for clean rooms as per pharmaceutical standards.

• Supervise installation of BMS system, calculation of CFM for air changes, Duct work installation verification & Valve installation verification.

Validation engineer, Dishman Pharmaceuticals and chemicals Ltd., India (April 2016 - April 2018)

• Execute, review and approve qualification protocols for manufacturing and packaging equipment’s.

• Execute review and approve qualification protocols for utilities like purified water system, compressed air, Nitrogen generators & HVAC systems.

• Supervision of validation activities in reviewing and approval of validation protocols for equipment’s, facility and utilities, which includes Installation Qualification, Operational Qualification and Performance Qualification.

• Maintenance, testing, installation & commissioning of pharmaceutical equipment such as Rapid mixer and wet granulator, Fluid bed dryer, Fluid Bed Processor, Vacuum Transfer Systems, Multi mill, Auto coater, Blenders and Tippler etc.

• Co-ordinate with safety engineer regarding process related safety requirements in case of solvent usage and hormonal product developments.

• Coordinate with project management regarding product developments and timelines. Assistant engineer, Indo-German tool room, India (Sept 2015 – April 2016)

• Development of 3D models by using Solidworks cad software.

• Creating final product drawing, product sequence drawing, process flow diagram and preparing tool schedule for every product.

• Assigned with the responsibilities of creating the dimensional drawings, main assembly drawings, part drawing and designing, and complete bill of materials.

• Interact with vendors for getting rate of components.

• Creating CAD models, manufacturing drawings, design calculation, related design documents.

• Coordinates activities concerned with technical development, scheduling to collect the data for new product development

• As a trainer provides training on CAD software and mechanical subjects, to the engineering students and other engineering organizations

Intern, Anupam – MHI, India (July 2013 – May 2014)

• Development of overhead submerged arc-welding process.

• Part design and assembly drawing by using Solidworks software.

• Planning and controlling of academic project work.

• Preparing of shop drawing and details etc.

TECHNICAL SOFTWARE PROFICIENCY:

Design Software: Solidworks, AutoCAD, Creo, Unigraphics CAD, Ansys Data Loggers Software: Testo and Vaisala (veriteq) Professional software: Microsoft Office & Microsoft Visio EDUCATIONAL QUALIFICATION:

Nirma University, Nirma Institute of Technology Graduation Year: June 2014 Master of Technology, Major: Mechanical Engineering, Minor: Computer Aided Manufacturing Gujarat University, Parul Institute of Engineering & Technology Graduation Year: July 2012 Bachelor of Engineering: Mechanical Engineering

PAPER PRESENTATION:

• Paper presentation on Friction drilling process (November 2013).

• Paper Presentation on overhead Submerged Arc welding Process (February 2014).

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