Summary
Overview
Work History
Education
Skills
Accomplishments
Industrial Visits
Personal Information
Languages
Timeline
Generic

Kalaiselvan B (H1B Visa)

Namakkal

Summary

Dynamic Senior Manager with extensive experience at Sthree Chemicals Pvt Ltd, specializing in green field projects and utility systems. Proven track record in project management and vendor management, leading a 40-member engineering team to successful project execution. Adept in GMP compliance and cleanroom standards, ensuring operational excellence and regulatory adherence.

Overview

13
13
years of professional experience

Work History

Senior Manager

Sthree Chemicals pvt Ltd
Ranipet
08.2024 - Current
  • Experienced in Handling of Green Field Projects in Active Pharmaceutical Ingredient (Creation of All Glass Unit, Production blocks, Warehouse, QC, R&D and Its Supporting Utility equipment’s)
  • Experienced in Handling of production Equipment Errection like SS Reactor, GL Reactor, Centrifuge, ANFD, RCVD, Blender, Micronizer & All glass Reactor
  • Experienced in Handling of Utility Equipment Errection and commissioning like Water Chiller, Brine chiller, Nitrogen Generator, Air Compressor, Pretreatment water system and Purified water system, Cooling tower, Boiler, ZLD, ETP, ETP RO, Fire Hydrant system, DG & Transformer
  • Experienced in Handling of Clean room project execution like ISO 7 & ISO 8 classification
  • Handling of overall Engineering team 40 Members (Mechanical, Electrical, Utility, Instrumentation, Civil)
  • Capable of handling the external vendors for the technical specification finalization and handover to purchase team.

Senior Manager

Nuray Chemicals pvt Ltd
Chennai
04.2019 - 07.2024
  • Experienced in Handling of Projects in Active Pharmaceutical Ingredient (Creation of All Glass Unit, Pilot Plant and Its Utility equipment’s)
  • Handling and trouble shooting of Production Equipment’s, HVAC system, RO plant, utility equipment’s.
  • Responsibility to follow up Capital expense preparation and approvals.
  • Responsibility to follow up projects (Preparation of Budgets, Planning and Execution)
  • Responsibility to follow up purchase department for project related activities.
  • Responsibility to follow up GMP activities related to regular maintenance of equipment’s and documentation related activities
  • Responsibility to follow up with external contractor for the project related activities for getting offer and making PO, execution and certification of bill after completion of projects.

Senior Associate Engineer

PAR formulation pvt Ltd
Chennai
11.2012 - 03.2019
  • Experienced in Qualification and Documentations like Area qualification, Equipment qualification, HVAC system qualification, Compressed air qualification.
  • Handling and trouble shooting of EMS system and BMS system.
  • Handling and trouble shooting of granulation, compression, coating, packing, HVAC system, RO plant, utility equipments.
  • Handling of serialization equipments in bottle packing line, blister packing line and pouch packing line.
  • Planning and executing of preventive maintenance and Calibration as per schedule.
  • Responsible to initiating of change control, incident, Deviation and other quality management system related to Maintenance department.
  • Preparation and uploading of SOP’s in Master control software related to Engineering Department equipments and providing the training to operators and Engineers in the facility.
  • Responsible to review assigning the SOP training in compliance wire and escalate to the team for on time completion.
  • Responsible to ensure on timely closure of maintenance related change control, incident, deviation and CAPA through review system and follow up.
  • Prepare and execute the qualification and requalification protocols for equipment and systems in accordance with approved procedures.
  • Any time Audit readiness, Review and closing of the CAPA’s for internal and external Audits.
  • Responsibility to review the alarms in EMS system and review of documents on daily basis for compliance of cGMP.
  • Shall operate the Utility equipments (Air compressor, chiller, HVAC and water system) and process equipments as per SOP instructions and enter the parameters which indicate the system performance in the log book.
  • Review of all documents related to calibrations and preventive maintenance performed by the maintenance department or outside agency.
  • Maintain a current list of instruments and measuring devices of process and utility equipments which require periodic calibration.

Education

Bachelor of Engineering - Electronics & Communication Engineering

Maharaja Engineering College
01.2012

Diploma - Electronics & Communication Engineering

P.G.P. College
Namakkal
01.2008

X -

Kongunadu Matriculation Higher Secondary School
Velagoundampatti
01.2005

Skills

  • Project management
  • Equipment maintenance
  • Cleanroom standards
  • GMP compliance
  • Utility systems
  • Vendor management
  • Team leadership
  • Budget preparation
  • Preventive maintenance
  • Troubleshooting techniques
  • Documentation management
  • Training development
  • Equipment decommissioning

Accomplishments

  • Achieved Five time 0/483 in USFDA inspection
  • Successfully completed MHRA inspection in 2015

Industrial Visits

  • Pune, Maharashtra, PAM Glat for BQS machine training
  • Pune, Maharashtra, PAM Glat for Coating machine training
  • Goa, Goa, Optel for serialization machine training
  • SMC Pvt Ltd training
  • HVAC system training
  • Bangalore, Karnataka, ISRO satellite center
  • Mangalore, Karnataka, Mangalore chemical and fertilizer Ltd

Personal Information

  • Date of Birth: 07/27/91
  • Nationality: Indian
  • Marital Status: Married
  • Place of Birth: Tamil Nadu

Languages

Tamil
First Language
English
Upper Intermediate (B2)
B2
Hindi
Beginner
A1

Timeline

Senior Manager

Sthree Chemicals pvt Ltd
08.2024 - Current

Senior Manager

Nuray Chemicals pvt Ltd
04.2019 - 07.2024

Senior Associate Engineer

PAR formulation pvt Ltd
11.2012 - 03.2019

Bachelor of Engineering - Electronics & Communication Engineering

Maharaja Engineering College

Diploma - Electronics & Communication Engineering

P.G.P. College

X -

Kongunadu Matriculation Higher Secondary School

Similar Profiles

CREATE PROFILE
Kalaiselvan B (H1B Visa)