R&D/Manufacturing Engineer

Nithesh Paramesh is a Mechanical Engineer with experience in the life science/pharmaceutical industry. He has performed a variety of duties that involve improving existing products, tooling and fixtures, project leadership, innovation, planning and engineering analysis and also participated in the areas of material control and flow including inspection. His experience includes: developing and managing validation activities, equipment/systems validation, cleaning validation for pharmaceutical products and experience in project management and coordination of the validation and installation activities with other departments. He has conducted GMP/ SOP Training for employees. He has experience working with manufacturing developing work instructions and validating manufacturing processes. He has experience in developing and updating product drawings, bill of material, and product specifications. He is adept in preparing documentation (components’ specs, bio-compatibility data, testing data, etc.), for CE Mark and 510K filing. He is familiar with building and testing hands-on prototypes and generating testing and validation reports. His personal attributes include leadership and sound judgment as well as creativity, analytical and troubleshooting skills and his ability to interact productively with people from diverse backgrounds.

EXPERIENCE HIGHLIGHTS

Pall Life Sciences

Covina

R&D Engineer, Cell Therapy

Nov 2010-Oct 2011 • Sourcing and Purchasing activities contributing to:

o Establishing and managing relationships with the external suppliers,

o Selecting suppliers and negotiating contracts,

o Organizing the delivery of services or goods,

o Ensuring the satisfaction of internal and external customers.

• Experience with project planning, documentation, and execution under Design Control.

• Completing accurate and timely preventive maintenance of equipment and tooling.

• Process Validation

o Developing and execution of Process Validation protocols (IQ/OQ/PQ) by reviewing the manufacturing procedures.

o Analyzing the process by preparation of the statistical data and finding process capability index to prove a robust process and validation.

o Reviewing the process and analyzing the sampling spots for process validation.

• Cleaning Validation

o Working on Cleaning Validation, to analyze the product integrity and its behavior in regards to the respective cleaning agents. Preparation and execution of Cleaning Validation Test Protocols and analyzing the critical areas for cleaning.

• Working with Manufacturing to develop work instructions and validating manufacturing process.

• Working and supporting, as a member of the Research and Development team, in developing and implementing new Cell Therapy products.

• Assisting in designing and developing prototypes for concept evaluation.

• Maintaining and updating design files throughout the product development cycle.

• Ensuring proper documentation completion to meet quality systems requirements (BOMs, product specifications, manufacturing process work instructions, protocols, etc).

• Responsibility in building and testing hands-on prototypes.

• Developing and updating product drawings, bill of material, and product specifications.

• Assisting in preparing and participation in technical reviews, and responsibility with organizing data and preparing appropriate documentation for assigned projects.

• Ability to reach project milestones, on schedule, with an aggressive timeline.

• Ability to solve routine design, engineering problems with assistance.

• Creating documentation (BPR, QAI, etc.), to support new and improved manufacturing processes.

• Building prototypes to confirm and verify consumer interest in a proposed design.

• Testing, evaluating and modifying the design, based on analysis of the prototype.

• Generating design files and maintaining it throughout the development cycle.

• Preparing documentation (components’ specs, bio-compatibility data, testing data, etc.), for CE Mark and 510K filing.

• Ability in communicating with different teams from different locations (TJ/EH/Woburn), for data gathering and provide samples to them for testing.

• Working with Product Engineering in maintaining design files and generating documents to fulfill design file requirements.

• Preparing engineering test samples (E-Lot).

Pall Life Sciences

Covina, CA

R&D Engineer Intern Aug 2010-Nov 2010

• Revision of Standard Operating Procedures and preparation of Master Batch Records for research and consumer products. Preparation and execution of qualification protocols and reports for manufacturing equipment.

• Preparing BOM, engineering drawings, work/assembly instructions, protocols and SOPs for manufacturing and assembling Cell Therapy products.

• Developing test plans, prepare appropriate documentation, performs engineering studies and reports test results.

• Preparing Failure Mode Effects Criticality Analysis (FMECA) and risk assessments for product and processes.

• Recommend design, processes, methods, techniques to improve quality, efficiency, flow of work, and productivity of current and future Cell Therapy products.

• Complying with legal requirements by adherence to requirements of existing and new regulations and legislation.

• Complying with all company policies and procedures. Ensures a safe and healthy environment by complying with all company safety policies and procedures.

• Working with outside vendors to identify and procure needed components for system designs.

• Assisting in process/product validations of new, existing, modified designs and processes.

• Working knowledge of inspection tools.

Pall Life Sciences

Covina, CA

Manufacturing Engineer Intern

Mar 2010-Aug 2010

• Supporting all Quality Assurance and Validation functions. Supporting technology transfer. Performing cleaning validations and equipment validations. Writing SOP's for quality assurance, maintenance, calibration, and use of equipment.

• Creating Validation IQ/ OQ/ PQ Protocols.

• Preparing work/assembly instructions, protocols and SOPs for manufacturing.

• Performing engineering studies, preparing appropriate documentation, and reporting test results.

• Preparing Failure Mode Effects Criticality Analysis (FMECA) and risk assessments for product and processes.

• Assisting in process/product validations of new, existing, and modified designs.

• Assisting in presentations, engineering evaluations and developing specifications for new equipments.

• Complying with legal requirements by adherence to requirements of existing and new regulations and legislation.

• Complying with all company policies and procedures. Ensuring a safe and healthy environment by complying with all company safety policies and procedures.

• Document tooling history.

• Develop and maintain up-to-date equipment files and database.

• Plan and carry out a calibration schedule for the equipment used.

• Raise purchase orders for consumables and equipment, following the relevant procedures.

CFD and Microfluidics Lab, San Diego State University

San Diego, CA

Lab Manager

Mar 2007-Mar 2010

• Training and supervising graduate level students with regards to clean room procedures, designing of layout masks for fabrication of MEMS devices and fabrication of these devices in the clean room from early concept generation through product end of life.

• Improving packaging design by identifying, testing, and evaluating new technology and solutions.

• Testing package design by preparing prototype package; conducting various tests.

• Resolving packaging problems by investigating damaged products; evaluating alternative solutions; incorporating changes.

• Ensuring a safe and healthy environment by complying with all the safety policies and procedures.

Overhauling Unit

KSRTC, India

Intern

May 2005-Jul 2006

• Developing tests and experiments on Bio-Diesel buses to simulate real world environments.

• Working towards improving specific fuel consumption and reducing emission percentages.

EDUCATION Master of Science, Mechanical Engineering (2010)

San Diego State University, San Diego, CA 2010

Bachelor of Science, Mechanical Engineering (2006)

VTU, India - Graduated in First Class Distinction (US Equivalent: Summa Cum Laude).

Presentations:

• Delivered an oral presentation on the “Influence of Coriolis force on DNA Migration and Hybridization in CD Micro fluidics Platform” at the Student Research Symposium 2010.The Student Research Symposium (SRS) showcased the research, scholarship, and creative activity of 419 SDSU undergraduate, masters’ and doctoral students.

• Delivered an oral presentation on the “Effects of Decarbonization on the performance and emission characteristics of a Multi-cylinder Diesel Engine” at the annual day celebrations.

PUBLICATIONS • Paramesh N, Kassegne S Influence of Coriolis force on DNA Migration and Hybridization in Compact Disk (CD) Microfluidics Platforms, Under Review Journal of Microfluidics and Nanofluidics, Springer-Verlag.

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