OBJECTIVE

Implementation of Process Design Engineering which utilizes my technical and organizational skills in the area of Pharmaceutical, Biotechnology, Fine Chemicals, Energy & Chemical and Nuclear Industries.

QUALIFICATIONS

Extensive and outstanding experience in process design, validation and construction covering bulk pharmaceutical, biotech and fine chemicals, energy & chemicals, specialty chemical, nuclear and polymer industries. Highly knowledgeable in all facets of pharmaceutical, biotech, energy & chemical and nuclear process design and validation including: process development, process optimization, material & energy balance, hydraulic studies, utilities, economic studies and evaluations, process flow diagrams (PFD’s), piping & instrumentation diagrams (P&ID’s), equipment specifications, instrument specifications, PLC & Delta V control systems, Piping Design using ASME B31.3 code requirements and validation protocol such as installation qualifications (IQ's), operational qualifications (OQ's) and performance qualifications (PQ's). Responsible for start up & commissioning, validation of equipments, systems and facilities at the various project sites. Responsible for bid analysis for equipments from vendors, audits at equipment vendors office and fabrication shop regarding equipment fabrication progress, Factory Acceptance Tests (FAT’s) of vendor provided equipment packages. Experienced with Primavera Project Planner & MS Project to define Integrated EPCV Project Schedule outlining WBS elements. Expert in writing Project Procedure Manual (PPM) and Project Execution Plan (PEP).

EXPERIENCE

Fluor Corporation, Greenville, SC November 2013-Present

Director Process Specialty Engineer

Process Lead for RTS (Return to Service) Project for Genentech, Vacaville, CA. Responsible for the optimization and revamp of existing Upstream Fermentation and Downstream Purification Process Design of Cell Culture Facility.

Process Engineering Lead for Apache Nitrogen Products Inc, Benson, Arizona. Resonsible for the supervision of Processs design of FEED package for Ammonium Nitrate Comlex to be designed by Tecnicas Reunidas and Linde. The facility includes Ammonia Plant, Urea Plant, Nitric Acid Plant, Ammonium Nitrate Solution Plant, Ammonium Nitrate Prills Plant, UAN Plant and DEF Plant.

Jacobs Engineering, Greenville, SC July 2012-October 2013

Senior Process Engineer

Process Engineer for NatureWorks LLC, Minnetonka, Minnesota. Prepared FEL1 (Feasibility, +50% TIC Scope and Estimate) documentation for a new facility to produce 150 kta specialty polymer in Southeast Asia. Responsible for preparation of process documentation including flow diagrams and the required equipment information. Process areas include lactic acid processing, polymer production, finishing and packaging, and required utilities and infrastructure.

Led process effort on design of paper Tissue and Towel machine facility for a Confidential Client. Anderson, South Carolina. Facility included new raw water treatment, effluent treatment, compressed air and steam generation. Developed P&IDs for effluent treatment palnt, compressed air and steam generation systems. Performed pumps sizing calculations using Pipe-Flo program.

PARSONS, AIKEN, SC November 2009-July 2012

Senior Process Engineer

Area process engineer for the process safety analysis and design of Salt Waste Processing Facility for DOE Savannah River Site, Aiken, SC. Responsible for detail safety analysis and pressure relief devices calculations for the entire facility. Performed detail pressure relief devices calculation and PSV tail piping design calculations using API 520 & 521, 2010 ASME Boiler and Pressure Vessel Code VIII and ASME B31.3 Piping Design Code requirements.

Fluor Corporation, Greenville, SC August 1996-October 2009

Director Process Specialty Engineer

LEAD PROCESS ENGINEER

Area process engineer for the process conceptual and basic engineering design and detailed engineering for retrofitting ACP, USEC, Piketon, Ohio facility for eighteen months to produce low enriched uranium hexafluoride utilizing state-of the-art technology. Implemented NRC standards, quality procedures and audits for the nuclear facility. Prepared material & energy balance, PFD’s, P&ID’s, equipment specifications, instrument specifications and piping design utilizing ASME B31.3 code requirements. Performed field walk downs for utility upgrades like compressed air systems and cooling tower water systems. Interacted with equipment vendors to expedite fabrication drawings for review and approval.

Lead Process Engineer for the process design of Large Scale Cell Culture facility for Pfizer Inc, County Cork, Ireland. Responsible for the Upstream and Downstream Purification Process Design of facility. Unit operations include r-Protein A Chromatography, Viral Inactivation, Q Capto Chromatography, Viral Removal Filtration, SP Sepharose Chromatography, Ultrafiltration/Difiltration, Formulation, Final Bulk Product Filling and Final Bulk Freezing & Final Product Storage.

Area process engineer for the process conceptual and basic engineering design of Multi-Product Cell Culture Launch facility for AMGEN, West Greenwich, Rhode Island. Responsible for the upgrade of Fermentation Area. Performed process design of replacing piping & instrumentation for the gaseous addition of air, oxygen & CO2 to existing seed/production bioreactors and addition of new Harvest disk-stack centrifuge skid and filter skid.

Area process engineer for the process safety analysis and design of Carbon Fiber plant for Hexcel Corporation, Decatur, Alabama. Performed detail safety analysis and pressure relief devices calculations for the entire plant.

Area process engineer for the process design of Anti CD22 Antibody purification process for Wyeth Biopharma, Andover, MA. Developed material balance, PFD’s, P&ID’s and equipment data sheets. Responsible for the optimization of existing process transfer panels to fit for the new Antibody process.

Lead Process Engineer for the process design of Bulk Humalog Manufacturing facility from conceptual into detailed engineering phase for ELI LILLY & Co in Carolina, Puerto Rico. Responsible for the process design of Purification Step of the facility. The facility is designed in a modular fashion. Significant features of the design are adaptability, state of the art automation, GMP concerns and a fully automated CIP system. Prepared System Requirement Packages and reviewed Functional Requirement to be used to code Delta-V automation system. Performed optimization of wastewater treatment capacity analysis for additional generated waste from expanded new humalog facility. Provided process support to Construction and Validation execution on site.

Lead Process Engineer for the process design of 300 MM$ Bulk Active Pharmaceutical Ingredients (API) facility for Pfizer/WARNER-LAMBERT in Singapore. Designed batch processes involving unit operation as hydrogenation, low temperature reaction, batch reaction, distillation, extraction, crystallization, filtration, centrifugation, drying.

Lead Process Engineer for the process design of multipurpose Bulk Pharmaceutical & Chemical (HOT CHOLESTROL DRUG LIPITOR) facility from conceptual through detailed engineering design and construction phase for WARNER-LAMBERT, Ringaskiddy, Ireland. Provided Process support to Construction and Validation execution on site.

Lead Process Engineer for the process design of Diagnostic Kit Manufacturing facility based on PCR Technology for ROCHE MOLECULAR SYSTEMS, Inc. in Branchburg, NJ.

Area Process Engineer for the Performance Qualification and Restart-up of STERILE & LIQUID PRODUCTION line at Hoffmann-La Roche, Nutley, NJ.

Lead Process Engineer for the on-site expansion of 15000 TPY Vitamin C facility for Roche Vitamins Inc., Belvidere, NJ. Responsible for fermentation sterilization automation, development of P&IDs, equipment specifications, instrument process datasheets. Provided process support for the construction phase of the project.

Lead Process Engineer for the process design of Acetic Acid Recovery system for Centeon, Illinois. Responsible in order to determine economic feasibility of recovering acetic acid from blood fractionation waste stream and reuse it for cleaning ion exchange column.

Lead Process Engineer for the conceptual/basic engineering design of the Large Scale Synthesis Center to be used for the simultaneous preparation of multiple chemical compounds to be tested in humans as pre-clinical trials for Ortho-McNeil, Raritan, NJ.

Foster Wheeler USA Corporation, Clinton, NJ March 1992- July 1996

PROCESS ENGINEER

Designed a high containment multipurpose bulk pharmaceutical facility from conceptual into detailed engineering phase for Eli Lilly & Co, Shadeland, IN. Responsibility also includes assisting in preparation of Operational Description, Functional Description. The facility is designed in a modular fashion. Significant features of the design are adaptability, high containment (dust exposure less than 1 microgram/m^3), state of the art automation, GMP concerns and a fully automated CIP system.

Designed high purity polycrystalline silicon facilities for a grassroots polisilica manufacturing plant for Advanced Silicon Materials, Inc., Billings, MT.

Area Process Engineer for Front-end basic engineering package for neopentyl glycol and 2-ethyl hexanol for Eastman Chemical Company, Kingsport, TN.

Prepared and executed validation protocols (IQs and OQs) of HVAC system for Granutac Inc., Wilson, NC.

Prepared economic feasibility study of a bulk penicillin facility for AECI, Ltd., in South Africa.

Lead Process Engineer for process design of a thiolactone unloading and solvent recovery plant for Hoffmann-La Roche, Nutley, NJ.

Developed PFD, heat and material balances, and process equipment specifications for an environmentally sound Beclomethasone process & Waste Water Treatment plant for Schering-Plough, Union, NJ.

Prepared and executed validation protocols for Schering-Plough, Union, NJ. Protocols included were Installation Qualification (IQ's) and, Operational Qualification (OQ's) of Kilo Prep Lab, HVAC System, USP Purified Water System and Clean Steam Generator System.

Validation Engineer for validation of Bulk Drug Manufacturing Facility for ICI Ltd, PA. Responsible for preparing and execution of validation protocols (IQs & OQs) for 750 Gal and 40 Gal Reactor System, Glycol Chiller System, Process Waste System and Vacuum Conveying System.

H. Reisman Corporation, Orange, NJ April 1991-February 1992

PRODUCTION SUPERVISOR

Managed a team of fifteen employees in a Toll Manufacturing Pharmaceutical facility. Responsibilities were process improvement, equipment selection, manufacturing support, production schedule, and people schedule and troubleshooting. The process involved weighing, blending, wet granulation, drying, milling, pulverizing etc. The work also included process validation for FDA approval, preparation of manufacturing procedures (SOP's), validation compliance to cGMP.

ICB Limited. Bombay, India September 1989-May 1990

PROCESS ENGINEER

Lead Process Engineer for process design of ABS plastic, Detergents and Nitro Aromatics projects.

INTEC Polymers Pvt. Ltd., Vapi, India October 1988-August 1989

PROJECT ENGINEER

Supervised erection and commissioning of Wire Enamel and Nitro Aromatic Plant.

KNIK Chemical Engineers Pvt. Ltd., Bombay, India August 1986-August 1988

PROCESS ENGINEER

Prepared Technical Economic Feasibility Report for the use of Waste Gas from Oil Refinery into Domestic purpose. Team member for acetaminophen plant design.

EDUCATION

Master of Science Chemical Engineering Bombay University India August 1986

Bachelor of Science Chemical Engineering Nagpur University India June 1984

PUBLICATIONS

Process Solids Handling Approach for Multi-Product Bulk API Facility, Pharmaceutical Engineering, ISPE, September/October 2006, Volume 26, Number 5.

REFERENCES Furnished upon request.

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