CURRICULUM VITAECURRICULUM VITAE

NIMESH PATELNIMESH PATELContact: Contact: +601136603458 (M-Malaysia) +919925478031(M-India)

E-Mail: E-Mail: nimeshbtech13@gmail.com

SNAPSHOT

An Engineering Professional with 14 years of rich experience in the field of Operation and Maintenance of Plant and Utility equipments. Completed degree in Mechanical Engineering from Reputed College. Worked with reputed Pharmaceutical and Chemical Industries and having in depth knowledge of the Plant Maintenance, Operations and Maintenance of Utility equipments, engineering services, Quality Systems, documentation etc.

Well versed with various activities Customers Audits Compliances, Regulatory Audit Compliances, Statutory Compliances, EHS Requirements, Internal Audits, Vendor Audits, Vendor development, Preparation of the reports and Performance Presentations, Risk Assesments, Planning and Scheduling of the Activities, Process Improvement and other continuous improvement Projects, Cost saving Projects, Training to down line team members for knowledge upgradation, Revamping of the Systems related to equipments and Infrastructures, Capex and Opex Budgets Preparation and its effective Monitoring, Parameters trending and take the necessary actions to ensure the smooth running of the systems etc.

Having knowledge of various standards and systems like cGMP, WHO Guidelines,ISO Guidelines, Pharmacopeia Requirements(USP, EP and IP Guidelines), GEP, GDP, HACCP etc.

Presently associated with Biocon SDN BHD, Malaysia as Manager – Engineering & Maintenance since November 2014. It is one of the Largest Manufacturing of the Biotech Products. I am taking care of the Drug Substance( API ), Drug Product(Formulations), Research and Development( R & D , Pilot Plant) and Utilities.

OVERALL JOB RESPONSIBILITIES

PLANT AND UTILITY OPERATIONS & MAINTENANCE

Planning and Implementation of the following category of Maintenance for all Pharmaceutical Process equipments. Preventive Maintenance Predictive Maintenance Breakdown Maintenance Opportunity Maintenance Shutdown Maintenance Corrective Maintenance

Implementation of the Preventive Maintenance Strategy based on the OEM Recommendations and also with Risk Based approach with due consideration of the criticality of the equipments with respect to Process

Requirements. Ensure that the timely completion and execution of the Preventive Maintenance with close co

ordination with the various sections. Implementation of the Predictive Maintenance tools and techniques based on the feasibility.

Monitoring of the critical parameters by using the Predictive Maintenance Techniques which helps to minimize the Possibility of the Plant breakdowns.

Analysis of the Breakdowns and take necessary actions to Prevent the breakdowns. In the event of breakdowns ensure that the turnaround time is maintained minimum and equipment is rectified in Possible minimum time.

Identify the correct route cause of the down time and take necessary CAPA to Prevent reoccurrence. Recording the MTBF and MTTR for the critical events. Make the Planning on the Oppurtunity Maintenance task to achieve maximum uptime of the

equipments. Preparation of the Shutdown Maintenance task and ensure that all the critical activities are

completed during this shutdown. Like Major Maintenance of the Electrical Panels, Refrigeration Systems Maintenance, Critical Process Equipments etc.

Maintain the critical Spares and Consumables to ensure the smooth running of the equipments. Tracking of the use of the critical Spares and ensure it is maintained as per the quantity mentioned in the ROL.

Ensure that the Historical trends are maintained for the Maintenance activities. Ensure that the smooth Maintenance Services are Provided all the time. Identify the bottleneck and Plant upset situations and take the necessary actions which are largely

some modifications, upgradations, revamping of the systems, some Improvements. Responsible for the Operation and Maintenance of the HVAC and Utility Systems. Ensure that the Clean room Parameters are maintained as per the Process requirements. Maintain the all Utilities in good conditions as per the requirement. Following are the Black and Clean

Utilities.Process Air, Instrument Air, Nitrogen, Plant Steam, Chilled Water, Chilled Brine, Cooling Water, Hot Water, Potable Water, Process Water, Purified Water, WFI, Pure Steam.

Ensure that the Utilities Generation and distribution cost is maintained optimum. Calculation of the total consumption of the Power and all other utilities. Preparation of the Technical and Commercial Comparison for the new Procurements. Technical

discussion with vendors and Service Providers for the explanation of the scope of the work and Specifications.

Finalization of the annual maintenance contracts with the OEMs for critical equipments to ensure that annual deep maintenance is done for the reliability of the equipment to deliver its Performance.

EXPOSURE ON THE PROCESS AND UTILITY EQUIPMENTS OPERATION AND MAINTENANCE

PROCESS EQUIPMENTS HANDLED

Fermenters – Make- Alfa Laval up to 50 KL Capacity with Double Mechanical Seals and Chemineer Mixers

Various Make Process Tanks with Top and Bottom Mixers of make GMM, Steridose, Sweden Rathi Power Transmission, Metenova, Sweden etc. Tank Capacity up to 56 KL

CIP Systems- DD Enterprise, Praj Equipments etc. Autoclaves- Make- Fedegari , Getinge, etc. Freezers- -80 Deg Cent- Make- Thermoscientific, Panasonic, Weiss etc Incubators and Shakers Centrifuge Machines- Make- Alfa Laval, GEA-West Falia Germany, Sukhras etc. Centrifugal Pumps- Make- KSB, Flowserve, Fristam, Alfa Laval,Kirloskar etc AOD Pumps- For Handling Acids Quattro Flow Pumps- for Handling of Buffer Solutions Reciprocating Pumps Metering Pumps Peristatic Pumps Gear Pumps Progressive Cavity Pumps Chromatography Systems- Low and High Pressure- Make- Novasep France Freeze Dryers- Make- Telstar Spain, Vertis- Germany, Top flow- Germany Crystallizers up to 15 KL - Make- EF, Morimatsu etc Cold Rooms- Carrier, Blue Star etc Deep Freezer Solvent Storage Tanks for IPA, Methanol, Toluene, up to 100 KL Capacity

Acid and Alkali Storage Tanks for HCL, Sulphuric Acid, OPA, Acetic Acid, NAOH, and many other chemicals.

Heat Exchanger(Shell and Tube and Plate Heat Exchangers)- GEA, Alfa Laval Graphite Condensers, Glass Condensers and other Glass Assemblies Glass Lined Reactor- up to 20 KL- Make- GMM, Nile, Stainless Steel Reactor- Up to 25 KL- Make- Dipesh Engg, Praj Industries, Metal Plantt Spray Dryers- Alfa Laval Spin Flash Dryers- Mojj Engg Systems Rotary Cone Vacuum dryer Rotary Vacuum drum filter Fluid Bed Dryer- Make Alliance Hot Air Ovens, Muffle Furnace Stability Chambers Incubators- Make Weiss Germany Multi Mill, Hammer Mill, Nauta Dryer Jet Mill, Pulverizer Vacuum Tray dryers Vacuum Pumps and Steam – Water Jet Ejectors Dry Heat Sterilizer Nutsche Filter- Dryer Vial Filling Line- Bosch Germany Vial Packing Line- Marchesini Formulation Vessels- Make Morimatsu- Sanghai Distillation Column for Solvent Recovery- Make Mojj, Praj Industry Multi Effect Evaporator- Alfa Laval Agitated Nutsche Filter and Dryer(ANFD)

UTILITIES EQUIPMENTS HANDLED

Purified Water Generation and Distribution System. Make- Stilmas Italy, Neela- India, Christ- Switzerland, TSA India. With HSRO and CEDI systems from Ion Pure. Capacity- 4 M3/HR and Storage Tanks up to 20 KL

Pure Steam Generation and distribution System – Stilmas Italy, Neela, Nilsan Nissotech, up to 2000 KG/HR Capacity

Water for Injection Generation and Distribution System Make- Stilmas Italy, Neela, Nilsan Nissotech capacity 2200 KG/Hour

Process Air Compressors- Make Atlas Copco, Kirloskar, IR, Chicago Pneumatic Instrument Air Compressors- Make Atlas Copco, Kirloskar, IR, Chicago Pneumatic Water Chillers- up to 300 TR- Make- Trane, Voltas, Blue Star, Kirloskar etc Glycol Chillers- Up to 250 TR- Make- Trane, Voltas, Kirloskar, Blue Star etc Nitrogen Plant- up to 600 NM3/HR Make- SAM GAS, PSA, Air Liquid, Linde etc RO Plant- up to 100 M3/HR- Make- Thermax, Neela, Doshi-Ion, Sigma Water, Permionics etc Softner- Up to 200 M3/HR- Make- Thermax, Sigma Water, Doshi-Ion etc. MGF- Make Thermax Fire Hydrant System Boilers- Husk Fired and FO Fired up to 12 TPH, Make- Thermax, Forbes Marshall etc Cooling Towers. Make- Paharpur, Varun, Advatech, Cooltech etc Capacity up to 2500 TR Waste Water Treatment Ultra Filteration System Thermic Fluid Heater ( 100000 Kcal/H) Make Thermax Vapour Absorption Chiller(VAC) Make Thermax upto 1000 TR DM Plant- Thermax- up to 200 M3/HR

HVAC,CLEAN ROOM AND OTHER EQUIPMENTS HANDLED

Air Handling Units( AHUs) Make- York, System Air, ABS,. Max Capacity up to 65000 CMH. More than 150 Nos of AHUs , Ventilation Units, Exhaust Units etc.

Dehumidifiers Bry Air upto 1200 CFM Laminar air flow units( CLAF and Moveable)- Bosch, ESCO, Suntec etc Bio Safety Cabinet for Grade A Air Supply- ESCO Isolators- Make Klenzad, Bectochem, Pharmalab, etc Static and dynamic Pass box Clean Rooms of Grade- A, B, C and D Air Supply. Air Curtains Dispensing and Sampling Booths, Isolators etc. Fume Hoods Scrubbers Building Management Systems Maintenance of the facility which involves the Infrastructure Maintenance. Activities like Epoxy

Flooring, Painting, Vinyl Flooring, PU Flooring etc.

EXPOSURE ON THE QUALITY SYSTEMS, GUIDELINES, DOCUMENTATIONS

Equipments Qualifications- In depth understanding of the qualification system. Well versed with the various documentations like URS, DQ, FAT,SAT,IQ,OQ,PQ for the Process and Utility equipments. Ensure that the equipments are qualified for its intended use and requirement. Active Participation in the various stage of the qualifications and ensure that the observations are closed as per the Requirements.

Good Command on the various documents like System Level Impact Assesment(SLIA) and Component Level Assessment(CLIA) for the equipments.

Requalification of the Systems- Ensure that the Systems are requalified as per the requirement. Critical Utilities like Air, Nitrogen are requalified periodically without deviation and ensure that it meets the Process Requirements.

HVAC Validation- Validation of the HVAC System according to the requirement of the Clean Room Grades. Checking of the necessary Parameters like Air velocity, Air Changes, Filter Integrity Test, Particle Counts etc. Perform the Static and dynamic Air flow Visualization Test(Smoke Test) as per the requirement.

Water System Validation- Well versed with the Water System requirements according to Indian and International guidelines. Validation of the water system for Phase-1 , Phase – 2 and Phase-3.

Handling of the Change Management, Deviations, OOT, OOS , IOC, Route Cause Investigation and CAPA with close co ordination with quality assurance and other departments.

Assist QA for Preparation of the Validation Master Plan and Site Master file. Preparation and review of the Standard Operating Procedures(SOPs) and Equipment Operating

Procedures(EOPs). Training to downline team for the cGMP requirements, SOPs on Operation and Maintenance etc. Handling of Various documents like equipment log sheet, Preventive Maintenance Planners, PM

Check lists, Facility Maintenance Check lists, History Cards, Maintenance Requisition Records, Trending of the Breakdowns, Trending of the Water System Parameters, Filter Replacement Records, Filter replacement Schedules etc.

Preparation of Protocols, Review and execution of the same. Assist other departments for execution of the Study Protocols, Various Process Protocols etc.

Maintaining the Various Plant Layouts like Equipment Layout, Man-Material Flow, Civil Layout, Area Classification Layouts and AHU Zoning Layout.

Maintaining Process and Utility P & IDs, GA Drawings and make the necessary changes if required. Handling of Audits by Various Customers, Regulatory Audits like USFAD,TGA, MHRA, WHO, EUGMP

and others.

PROFESSIONAL EXPERIENCE

SR NO

Company Name Designation From-Month/Year To- Month/Year

1 Biocon SDN BHD,Malaysia Manager-Engineering and Maintenance

Novemeber-2014 Present

2 CadilaHealthcare Limited Manager-Engineering March-2014 October-2014

and Project3 Fermenta Biotech Limited Manager-Engineering

and MaintenanceMay-2013 March-2014

4 Nectar Life Science Limited Manager-Engineering and Maintenance

November-2012 May-2013

5 Anil Limited Manager-Maintenance December-2009 November-20126 Bisazza India Limited Assistant Manager-

MaintDecember-2006 December-2009

7 EI Dupont India Limited Team Member January-2006 December-20068 Piramal Glass Limited Jr. Executive July-2002 January-2006

PERSONAL DETAILS

NAME:- PATEL NIMESH KUMAR ISHWARLAL

PRESENT ADDRESS S- 03/05, FAIRWAY SUITESHORIZON HILLS, NUSAJAYAJOHOR, MALAYSIA

PERMANENT ADDRESS 51, ASHRAY BUNGLOWSBARODA EXPRESS WAYCTM, NH-8,AHMEDABAD-380026GUJARAT,INDIA

PASSPORT NO M 1024757

MARITAL STATUS MARRIED

EDUCATIONAL QUALIFICATIONS BACHELOR OF ENGINEERING(MECHANICAL)DIPLOMA IN ENGINEERING(MECHANICAL)

NOTICE PERIOD 2 MONTHS

PRESENT SALARY

EXPECTED SALARY

Note- References will be given upon request.