Yogesh Kulkarni (B.E.Instrumentation)Rahi Mansion, Plot No. 208 / 209 / 212 / 213, Flat No. 303, Sector No 4, New Panvel (East) Pin: 410206.Mobile: 9820444527Email: yogiiee@rediffmail.comDOB: 12th Sept 1969

Professional Summary:

Over 20 years of proven work experience in Pharma sector with domain knowledge of Engineering function. Also worked Regulatory Audits and compliances area.

Experience:

Sandoz India Private Limited (Since November 2004 till Date)

It’s a generic arm of Swiss based multinational organization “Novartis”. Fortune 500 and one of the world’s best Employer Organization. Work at Turbhe Site with API manufacturing capacity in Cephalosporin and Carbapenem products for all regulated and unregulated markets.A 100 % export oriented manufacturing unit with an approval from authority like USFDA, EU, TGA, MCA, MHRA for API, Sterile API and FDF.

Career Roadmap

Head Engineering at Sr. Manger level at Sandoz Turbhe since June 2015

Project Manager for SAP Implementation and having master access for entire Sandoz India.

Joined as Sr. Executive – Engineering in 2004 at Turbhe site

Job Responsibilities

Engineering Control

Managing the Planning / Budgeting Process for the Capital and R&M. Key decision maker at India level for the Global / Top management approval.

Good analytical skill and provide timely, precise and accurate MIS to top management to facilitate Key Decision making.

Strong control on Budget Spending by Supervising & coordinating entire activities with periodical review.

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Areas of Expertise:

Project Management Budgeting and Costing Facing Regulatory Audits Audit Compliances. ERP (Super User for SAP-PM ). SAP Implementation on all Sandoz

sites Implemented ISO system – 14000 and

18000 Team Leader. Computer system validation

documentation

Soft Skills:

Result Driven. A team Player Technical Trainer Excellent communication skills Self-motivated Goal oriented Persistent

Project Controller: End to end tracking of any capital projects from preparation of project document, Qualification and then successful installation of the project.

Ensure Strict adherence to set quality and safety standards in engineering area in plant by optimal use of resources available.

Led regulatory audits for the site for engineering function independently and successfully.

Instrumental in implementation of statutory and GMP compliance in plant.

Mentor and Coach team in their development and support in trouble shooting in their activities.

Effective utilization of manpower for attending daily breakdown jobs and preventive maintenance to ensure least breakdowns and successfully achieved production targets.

Good knowledge in the area of cGMP, HSE & statutory compliance.

Core Team Member in successful implementation of ISO 14000 and OSHAS 18000 on site.

Implementing closure compliance for engineering related activities.

Super User (SAP PM module) – Since 2009

Played vital role in SAP implementation and post as a Super user to support all the sites in resolving initial problems and thereby saved company revenue spent on consultant. .

Coordinator with Final Users for any changes in the configurations.

Training and assigning role to new joiners in SAP module.

Projects & Achievements

Done Upgradation of Emerson’s delta V foundation field bus system from version 4.2 to version 8.4 with computerized system validation documents

Done retrospective validation and documentation for User account management and audit trail functionality implementation for Rockwell SCADA system

Implementation of SAP – PM module at Sandoz India sites

Involved in CSV assessment for PARAXEL observation and compliance

Key role in Energy saving projects which included : Replacement of utility pumps with VFD driven energy efficient pumps for Chilled water, Chilled

glycol, cold glycol and cooling water

Replacement of - 25 degree STAL make glycol chiller with VFD driven Voltas chiller

Use of 250 TR stand by Trane chiller of chilled water in place of 275 TR Trane chiller

Installation of VFD for Air Compressor

Installation of Access Control System with CSV documentation

Green Energy by using PNG instead of furnace oil in boiler operation.

Installed Cryo Condensation Plant for VOC emission control

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Emmellen Biotech Pharmaceutical Limited (from Feb 1996 till November 2004).

World’s second largest manufacturer of Ephedrine and Pseudo Ephedrine hydrochloride and

it’s derivatives used in cold and cough range.

Position – Sr. Executive – Instrumentation

Job Responsibilities:

Worked on the project of Automation which included :

Designing of Yokogawa DCS system according to the I/O’s.

Erection and Commissioning of Yokogawa (Micro-XL) DCS.

Procurement of all the field instruments.

Control loops checking and commissioning.

Calibration of all field instruments.

As company was going for USFDA certificate

Preparing calibration sop’s and schedule for all the field instruments.

Calibration of all the field instruments as per the sop and schedule.

Maintaining the calibration records of all the field instruments.

Monthly updating the list of total field instruments.

Preparing documentation's like PPM schedules, calibration certificates, work

records, check lists for every instrument under calibration and keeping their records

month wise as per the requirement of USFDA.

Getting done the calibration of Master instruments from external agency

Done Retrospective Validation of Chartless Recorder and DCS system .

Routine maintenance and new projects

Carrying out breakdown and preventive maintenance of the instruments

Preparing yearly budget and Spare parts planning and procurement of same

Looking after the new upcoming projects which includes, Sending inquiries to vendors, Getting quotations, making comparative statements, Selection of proper instruments and finalization of purchase order

Academic Qualification:

Bachelor in Engineering (B.E.) in Instrumentation stream from Government College of Engineering, Pune University in July 1995

Diploma in Instrumentation Engineering from Bhartiya Vidyapeetha, Mumbai in July 1991

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