SRAVYA KOTHA

Name: Sravya K
Phone: 678-212-5556
Email: mailto:ksravya88@gmail.com
Home Location: US-MA-Everett-02149 (Have H1 Visa)

Will Relocate To:

Experience
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Most Recent Title: MES Engineer
Experience: 5 Years, 7 Months
Most Recent Pay:
Managed Others:
Spoken languages:
Sec. Clearance: No
Certifications:

Company Information
Start Date: November 2015 ~ End Date: September 2016
Company Name: Shire Pharmaceuticals
Job Title: MES Engineer

Start Date: October 2014 ~ End Date: September 2015
Company Name: Ariad Pharmaceuticals
Job Title: Automation Engineer

Start Date: July 2012 ~ End Date: June 2014
Company Name: Dr. Reddy’s Laboratories
Job Title: Process Engineer

Start Date: May 2011 ~ End Date: June 2012
Company Name: Aurobindo Pharmaceuticals Pvt. Ltd
Job Title: Process Engineer

Start Date: November 2010 ~ End Date: April 2011
Company Name: Vasant Chemicals Pvt. Ltd
Job Title: Chemical Engineer Internship

Education
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Not Provided

Desired Position
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Job Type:
Desired Pay:
Max Commute:
Travel Preference:

Interests
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Architecture (No experience)
Construction Engineering – Architecture – Surveying (No experience)

Resume
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SRAVYA KOTHA

Phone: +1 (281)-710 -2780
Email:ksravya88@gmail.com

PROFESSIONAL SUMMARY

* Nearly 7 years of experience in supporting process, manufacturing and automation systems in
pharmaceutical and biopharmaceutical industries.
* Experience in Shop floor Processes and MES Implementation using different technologies such as Syncade,
PAS-X
* Hands on Experience Implementation on Weigh & dispense functionality, EBR functionality,
Warehouse Management, Equipment Management, MBR, Material Track and Trace and e-log books
* Server, Client configuration and System administration of Syncade and PAS-X
* Gathering MES requirements, Design, Develop and deployment of MES systems
* Experience in Process Factory Automation Application development using different technologies
such as Siemens S7-300/400 PLC, Delta v in various industries
* Knowledge of PLC Programming, implementation and troubleshooting.
* Identification KPI (Key Performance Indicators) for the processes and ensuring the KPI data
visualization through shop floor integration with ERP systems with MES
* Skilled in good team work, independent functioning, taking up new challenges planning and
execution of ideas
* Proficient with interfacing MES systems with plant automation systems and data collection
historian systems
* MES System interface with LIMS and other quality systems with real time problem identification
and resolving
* Knowledge of shop floor manufacturing, cell culture, recovery, purification operations with S88
and S95,integration of MES systems with DCS/PLC/SCADA with ERP/Business Intelligence systems
* Maintenance of Field Instruments like I/P, Control Valves, Transmitters and other industrial
instruments of Pressure, level flow, Temperature.
* Experienced in performing Gap Analysis for 21 CFR Part 11 and validating documents according to ISA
Standards.
* Skilled in process development, simulation process and equipment design with focus in continuous
* Experience in the integration of S88 automation systems with S95 manufacturing execution system.
* Experienced in resolving unusual and complex industrial automation system problems.

TECHNICAL SKILLS

Control System Delta V, Honeywell EPKS, C300 controller, Siemens S7 – 300/400 PLC
Manufacturing execution system
(MES)
Syncade, PAS-X
Operating Systems MS-DOS, Windows Server, XP, Windows 7
Database SQL Server 2005 and 2008
BioPharma CGMP, GAMP, S88, ISA95, 21 CFR Part 11
Software tools & programming
C, C++, VBA, VMware, AutoCAD 2007

Team Management Project Requirement Analysis, Design, Development, Testing and Implementation
Project Management SAP MM module, Six Sigma, Root Cause Analysis

EXPERIENCE

Shire Pharmaceuticals – Lexington, MA Nov 2015 – Sep 2016
Role: MES Engineer

Responsibilities:

* Defining functional requirements for MES solutions through documentation analysis and
implementing the test Syncade MES Solutions that meet client requirements.
* Supporting the implementation of the MES application and subsequent development of electronic
batch records (eBRs) for manufacturing operations
* Analyzed and documented the utilization rates of the equipment in manufacturing lines and the Overall
Equipment Effectiveness (OEE).
* Creating prototypes to develop and demonstrate special project features such as Design, implement
and test complex MES solutions to meet customer requirements
* Regular maintenance and support for the Syncade MES and the electronic logbooks for the process
and operations
* Monitored the deployment of the bidirectional interface between MES and SAP Saturn by using iDoc
service.
* Played key role in integrating shop floor data with OSI PI historian EMDVBCS interface systems
with Syncade events and electronic work instructions data configuration
* Configured the operator interface for Syncade Weigh and Dispense for all raw material to reduce
variability with point of use verification, forward and backward traceability
* Responsible in teams to define scope, sizing, system/operational requirements, integration
requirements, support project estimations and execution methodology like documentation analysis
* Implemented the Overall Equipment Effectiveness (OEE) methodologies like planning, scheduling,
order generation and tracking with complete understanding of shop floor and manufacturing floor
operations.
* Developing General Design Specifications (GDS), Detailed Design Specifications (DDS), Functional
Requirements Specifications (FRS) and validation documentation
* Identified and analyzed defects throughout the production sequences, to be able to recognize in
real time the several quality problems that may occur in the production processes
* Materials management and facilities status reports, order creations and maintenance with the
Syncade MES and Delta V systems
* Worked with operations to determine project needs and to support them through configuration
changes and master data changes in Syncade to validating tools used in the qualification of
Master Batch records

Ariad Pharmaceuticals, Cambridge, MA Oct 2014 – Sep 2015
Role: Automation Engineer

Responsibilities:

* Resolved part and assembly discrepancies to facilitate automated processes
* Attended the training on PAS-X and managed the implementation of MES projects
* Developed the Master Data Creation and Maintenance SOP (Standard Operating Procedure) in
coordination with the PAS-X MES Master Data Specialist.
* Knowledge of engineering documentation required for cGMP process equipment, software lifecycle
documentation and GAMP guidelines
* Understanding cGMP software quality system principles and sanitary equipment design requirements
* Design and modify Master Batch Records, Generic Master Batch Records, Parameters Value Lists
according to the specification of each product and/or equipment.
* Completed the implementation, validation and testing of the PAS-X interfaces with ERP systems and
OSI PI system
* Control Library and virtual control utilization for the advanced controls and optimization of the
operations.
* Supported the creation of a Special Protocol generated to verify, test and approve the new
electronic mater Batch Records and Cleaning Records using PAS-X 3.1.7 Developed the documents for
FAT, SAT, Functional Specifications, Control specifications and operation manuals
* Implementation and maintenance of Siemens SIMATIC PLC for process control and machine automation
in biotech and pharmaceutical manufacturing
* Recipe verification, process cells, graphics and phase parameters for the GMP environment
* Customized Control Strategy and Sequential Control Module customization, customizing alarm for
project specific requirements on Experion DCS system
* Preparation and configuration of Master Data, Client and Scale Profile, Parameterization, Master
Batch Record (MBR) Design and execution of PAS-X for Mock trials

Dr. Reddy’s Laboratories July 2012 – June 2014
Role: Process Engineer

Responsibilities:
* Assisted product development in quality control procedures, development of test protocols for new
equipment procurements (IQ/OQ/PQ) and introducing test practices to manufacturing
* Involved in design control activities, worked on end of life changes controls
* Assisted for writing change control SOP’s to comply with 21 CFR part 11 requirements
* Delta V controller logic customization for the pharma intermediate products as per the Standard
Operating Procedures and operations manual
* Delta V system maintenance for the Simple and Vacuum distillation for the batch manufacturing
operations
* Root cause analysis of process deviations with Fish Bone diagram and preparation of investigation
report
* Ensuring 5S implement and familiarizing plant personnel with Hazop study documents for the
process
* Performed pharmaceutical manufacturing operations in cGMP environment according to Batch
Manufacturing Record (BMR) specifications

Aurobindo Pharmaceuticals Pvt. Ltd – India May 2011 – June 2012
Role: Process Engineer

Responsibilities:
* Evaluate the current validation scenarios and identify the gaps in validation by performing gap
analysis
* Assist in collecting data for Cleaning Validation Protocol for cleaning of manufacturing
equipment used in the solid dosage from manufacturing equipment train
* Review of heat exchanger design for counter current flow including pinch analysis for optimum
column
* Siemens PLC logic implementation for agitation system along with motor controls with ladder logic
* Performed McCabe- Thiele analysis for optimum column design
* Knowledge in pipeline sizing, sizing of Knock out drums, pump selection & sizing and pressure
drop calculations
* System administrator for the ERP system for the manufacturing and management facilities

Vasant Chemicals Pvt. Ltd, Hyderabad Nov 2010 – April 2011
Chemical Engineer Internship

Responsibilities:
* Training on operation of simple vacuum distillation columns, batch reactors, dryers and
evaporators.
* Laboratory analysis on pharma intermediates 2- Amino biphenyl and Para amino Benzo Nitrile(PABN)
using CGS and gas-liquid chromatographs, centrifuges and analyzers.
* Involved in reactor design for two ideal reactors (PFR- plug flow reactor and CSTR- Continuous
stirred tank reactor) using Matlab.
* Process analysis by identifying the equipment, mass and energy balances.
* Designed and simulated a process to produce synthesis gas from Natural Gas through steam
reforming, series of combustion reactions and water gas shift reaction on Aspen Hysys
* Developed a PID control model and tuned the controller P gain, I gain and derivative gains in MATLAB
Simulink for the level control of the tank