Bhamidipati B Sitaramam

Sr. Manager in Engineering & Projects

AMNEAL Oncology Pvt. Ltd

05.2015 - Current

First line member of USFDA in 2016, 2018, 2019 and 2023
First line team member in approved CANADA Audit in 2016
First line team member in DUTCH (MHRA) audit completed
Executed projects: Introduction of Paclitaxel product
Facility modification for introduction of new equipments for manufacturing of paclitaxel product in liquid line and PFS line manufacturing area
Paclitaxel product manufacturing process equipments and required utility equipments technical finalization, installation and commissioning
Installation and qualification completed for two brain chillers, one hot water system, five manufacturing vessels, CIP & SIP skid, Tangent flow filtration, inline homogenizer and high-pressure homogenizer etc
Replacement of existing powder line: Fabtech Vail washing machine, tunnel with NKP powder filling machine with isolator powder filling line is replaced with Romaco robotic powder filling machine with Klenzaids Tunnel and washer
All documents provided and supported for validations all utilities, HVAC, area modifications as per the requirement is provided with necessary validations
Commercial batches are successfully produced
Powder filling line: Fabtech Vail washing machine, tunnel with NKP powder filling machine with isolator powder filling line with manufacturing, filtration vessels, external drying machine integrated line project executed
All documents provided and supported for validations all utilities, HVAC, area modifications as per the requirement is provided with necessary validations
Commercial batches are successfully produced
Trucking liquid filling line: The existing liquid filling line replaced with trucking vial washing machine, Tunnel, 12 head liquid filling machine with two auto loading, unloading systems for two Lyophilizes each 10 cum, vial ceiling machine, External drying machine with isolators
All utilities, HVAC, area modifications as per the requirement is provided with necessary validations
This line is suitable to execute the vials from 2 Ml to 100 Ml
Necessary support give for validations and completed the projects
Commercial batchers are executed after successful media fill results
Enhancement of Water system: Successfully completed Water system PW and WFI storage and distribution loops with SCADA system are executed with 6 Kl and 3 Kl storage capacity tanks respectively with required qualifications
1000 kg / hr pure steam generator and 1000kg/ hr
WFI generation plant installation and qualifications are completed and released for regular usage
Chemical subitizable reverse osmosis 12 cum / hr capacity installed and validated in raw water area
Paclitaxel Project: Prefilled syringes line converted in to paclitaxel manufacturing line by introducing of major equipments High-pressure homogenizer, in line homogenizer, 500 to 5 liters vessel brine chillers and hot water system project executed with filtration vessel, HVAC, utilities and Facility modification and qualifications completed
Enhancement of power control center: 1600 KVA transformer with 33 KV VCBs and PCC distribution panel installation completed and released for regular usage
Enhancement of utilities: 350 TR Trane chiller installation and commissioning in utilities, 2.8 TPH boiler installation with chimneys, 495 CFM Atlas Copco Air compressor with drier
Operational excellences: Cost saving projects are Implemented and achieved the targets as per below: Steam condensate recovery system from water system and HVAC to boiler feed water tank, Power factor correction and maintain up to 0.99, Water system chemical consumption Decreasing, Fuel ionizer consumption Boiler by installing fuel catalyst, VFDs installation in Cooling tower FANs, Complete condensate recovery
Planning of new facilities, electrical, utilities and supporting in equipment finalization
Administer expenditure controls and estimating construction costs
Appropriate installations of utilities with supporting documents
Documentation of all the area and equipment in utilities, HVAC and clean utilities with documentation
Preparation of budgets for opex and capex as per the approved
Preparation, monitoring the preventive maintenance policy of the planned equipment and utility
Responsible for process of raw utilities, HVAC and clean utilities
Knowledge in QMS documents like Change controls, Deviations, Validation etc
Planning and supporting in new projects introduction of PFS line facility and powder process line Routine maintenance activities also monitoring
Daily operation monitoring in utility, HVAC and water system area with help of executives
Completion of maintenance and project activities within the time line
Completion of projects with support of vendors and consultants

Engineering Supervisor

Hyderabad International Convention Centre & Novotel

03.2006 - 05.2015

Supervision of maintenance of all Equipment
Planning of manpower as per requirement
Monitoring of daily consumption
Preparation of log sheets, schedules for preventive maintenance
Forecasting of spare parts, Venders follow-ups

VENENBURG IT PARK (J.E Enterprises)

Hyderabad

08.2004 - 03.2006

Programming and software provide by Johnson Control & Siemens India Ltd
Operation and maintenance of Screw Chiller with B.M.S
Maintaining water cooled chillers of 360 TR-3Nos
Air Cooled Screw Chillers of 270 TR-3 Nos
Air Cooled Screw Chiller of 180 TR-4 Nos
Air Handling Units-150 No

RAMOJI GROUP

Hyderabad

08.1997 - 08.2004

Supervising of Erecting of

Summary

Overview

Work History

Sr. Manager in Engineering & Projects

Engineering Supervisor

Education

DIPLAMO - ELECTRICAL&ELECTRONICS ENGINEERING

INTERMIDIATE - M.P.C

Electrical 33 KV Supervisor license -

Skills

Personal Information

Timeline

Sr. Manager in Engineering & Projects

Engineering Supervisor

DIPLAMO - ELECTRICAL&ELECTRONICS ENGINEERING

INTERMIDIATE - M.P.C

Electrical 33 KV Supervisor license -

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