Education

Master of Engineering in Mechanical Engineering, GPA: 3.3/4.0 May 2016

Lamar University, Beaumont, Texas

Bachelor of Engineering in Mechanical Engineering, GPA: 3.4/4.0 June 2013

Gujarat Technological University, Ahmedabad, Gujarat, India

Professional Experience

Manufacturing Engineer Aug 2017- Current

Zimmer Biomet, Memphis, TN

Prepare and update Inspection Method Records (IPRs), routers for Implants and instrument for different families (e.g. vitality, Polaris, Durango, Alta etc.)

Provide an On floor support for Inspection method records, GD & T issues in Blue prints, BOM Issues, Supplier Inspection Issues.

Support for Creating Standardization Work Instruction for Efficient output during Packaging, and Inspection Line.

Create a Work order Routers for SISP, FIP, FWIP, FISP, SWI Line using SAP.

Updated Printed Materials Specifications, Packaging Bill of Materials, Shipping Bill of Materials, Operation procedures and Unique List Numbers.

Provide a Sufficient Guidelines and support to inspectors to Measure a Feature of Implants, Case, and Instruments using CMM, Micrometer, Calipers, Go No Go gauges, comparator etc.

Creates Inspection method records and MCO using Bill of materials (BOM), and Blue Prints.

Provide Support for Process validation Protocols (IQPQOQ) According to FDA and GMP Requirements.

Validation Engineer March 2017 – Aug 2017

Adello Biologics/TPSI, Chicago, Illinois

Prepared validation protocols for equipment, facility and utility

Reviewed SOP’s and followed the guidelines of the current GMP for the clean room environment provided by FDA

Performed Environmental Monitoring Performance Qualification

Reviewed MEP (Mechanical, Electrical, Piping),Pressure flow, ISO classification, Floor diagram, and equipment diagram drawings

Prepared IOQ protocols for Equipment’s, Facility, and Utilities according to 21 CFR Part 11 and cGMP Requirement.

Updated the SOP’s of Environmental monitoring, Good documentation, cleaning or sanitization, Viable, Non-Viable monitoring, Gowning procedure, material and Personnel flow and related SOP’s of facility and Equipments.

Updates and Creates User Requirement specification of Equipments and facility (E.g. Laminar flow hood, Incubator, Bio reactor, Ultra filters, Refrigerator Bench Scales etc.)

Executes the Installation, Operational, and Performance qualification protocols for Facility and Lab equipments.

Working on temperature, Humidity, Air balancing, HEPA leak, Material of construction test.

Creating and co-ordinates for approval of Change control for facility as well as equipments.

Validation Engineer-Trainee July2016–February 2017

Amneal Pharma/TPSI, Hauppauge, New York

Updating and verifying Calibration reports of equipments.

Prepares IQ/OQ/PQ protocols for facility, Utilities, and manufacturing Equipment (Including grinding and mixing, Compression, Packaging department) according to 21 CFR Part 11 and cGMP Requirement.

Created and Executed IOQ and PQ protocols for Laser Printing machine, Fette 3200 I tablet press, Automatic labeling Machine, V blender,etc.

Updating and maintains Validation master plan.

clean environment, commissioning and qualification of pharmaceutical equipment and systems

Field testing, troubleshooting; project coordination and documentation, and Start-up of operations.

Supporting Engineering Project's activities from documentation and drawings to specifications and coordination of changes as well as deliverables through project's life cycle.

Compressed Process Air; Process Monitoring, and Process Equipment’s installation, start-up, commissioning, and qualification for Bio-Pharma Industry

Reviewed MEP (Mechanical, electrical, Piping, HVAC Drawing) drawings, test utilities, test documents and specifications for Facility protocol.

Quality Engineer January 2013 - june2014

Ritul Engineering Pvt Ltd., V.V nagar, India

Check and Approve documentation Trough Test validation methods which ensures quality of product and measurers.

Finding a Non-conformity using Root cause method.

Check And verify documentation of manufacturing process Quality through R & R Gauge and CAPA study

Using cpk and ppk and normality test measures the process capability and defective rate.

Review CAPA files and assess adequacy based on defined evaluation criteria. Remediation Plan execution for CAPAs and SCARs

Academic Projects

Gym equipment modeling with Creo Parametric

Re-evaluated design specifications by performing DFA and DFM in order to improve efficiency and cost

Analysis on the Effects of Process Variables on TIG Welding

Calculated factorial fit on Minitab for the welding current, speed and shielding gas flow rate against penetration depth

Structural and Thermal Impact analysis with ANYS

Studied the stress and strains analysis of Thermal, load and pressure Impact on Knuckle joint, Crank Shaft, piston and cylinder using the ANSYS tool.

Technical Skills

CAD Softwares: Creo/Pro-E, Solidworks, Catia, Inventor, AutoCAD and FEA with ANSYS

Documentation Tools: Word, Excel, Outlook, PowerPoint and Adobe Acrobat Reader

IQ, OQ, PQ, MEP design, CAPA, TMV, GMP, cGMP, Track wise, 21 CFR part 11, ISO guidelines for clean room environment, Process capability, cpk, ppk, normality Test, Aseptic processes.

PPAP, WCCA analysis, Statistical decision making, six sigma, GD & T.

Certifications

Pro-E for Design Engineers PTC University

Personal Strengths

Strong communication, analytical, technical writing, organizational and interpersonal skills.

Team Member, self-motivated, Enthusiastic and highly service oriented.

Open to relocation with or without assistance and willing to travel as required.

Contact this candidate