HERLIEN KINGSLEY R

Manager Engineering-HOD

Indian Immunologicals Limited

Ooty

01.1998 - 12.2021

Regulatory:
Compliances, approvals, and renewals related to: CPCB, SPCB, CEA, SEA, Explosives, FIRE & Safety, Boiler, Environmental Monitoring, CGMP, WHO, ISO, OHSAS, PICS, USFDA, and CDSCO.
Water Treatment:
Ensuring the water treatment meets the required parameters from raw water to WFI.
Installed and commissioned the PW plant and WFI plant, along with loop systems, and carried out the qualification of the new lines as per cGMP guidelines, completing the validation process for all four seasons.
Monitoring the water results with respect to bacteria, fungi, conductivity, endotoxins, etc. With in-process QC, ensure actions at alert stages to avoid a halt in production due to water issues.
Investigating and proposing an action plan for various water-related failures, arranging the required resources in manpower and materials to carry out the activity on time.
Effluent Treatment:
Primary treatment plant in SS using hot steam sterilization process for killing viruses of 15 KLKD receiving capacity and 4 KLD treated water output for 24 hours operation, ensuring 100% elimination results.
The secondary effluent treatment plant, with a capacity of 35 KLD, operates 24/7, involving biological processes and hydraulic retention times for effective treatment and reuse of water for garden maintenance, thereby ensuring a ZLD process.
Obtained CTO for expansion from 6 million doses per annum to 12 million doses per annum capacity without a change in the existing infrastructure and capacity.
Installation and maintenance must meet the required limits of various pollution control parameters, connected online 24/7 with both CPCB and TNPCB, related to treated effluent, ambient air quality, and stack emission parameters.
HVAC:
Two different pressure differential areas for production activity handling virus culture in negative pressure cascading and 100% exhaust—cell culture, ascetic filling, and capping in positive pressure cascading up to Grade A are effectively handled without cross-contamination, personal safety, and environmental safety.
Coordinating with HVAC designs by providing the required input for new systems, installing, and commissioning the HVAC systems to maintain temperature, differential pressure, and relative humidity as required for product manufacturing, QC testing, the animal house, office area, etc.
The HVAC system is overlooked and certified for DQ, IQ, OQ, and PQ at all stages of production, installation, commissioning, qualification, and revalidation.
A planned preventive maintenance and filter replacement schedule are enforced for an effective HVAC system. Troubleshooting the air balancing issues with respect to ambient changes, etc.
PM and BM - Maintenance:
Coordinating with production to release and restart the machines before and after PM, without sterility issues. Reviewing the stock position at the stores after the PM activities, and following up on indents for the further procurements.
Equipment covered: mixing vessels, RCA, Lafus, pass boxes, autoclaves, DHS, hot rooms, concentration equipment, zonal centrifuges, ultra freezers, deep freezers, vial washing machine, sterilizing tunnel, filling machine, freeze dryer, sealing machine, labeling machine, ZC air compressor, AHUs, clean room. Boiler reciprocating air compressor, PSG, WFI, UPS, DG sets, PCC/MCC panels, HT yard, QC test, and incubation instruments with respect to mechanical, electrical, and instrumentation.
Analyzing the severity of the breakdown and its implications on the process, making ourselves available at the factory during odd hours or holidays, if available locally.
Validation and Calibration:
Co-ordinate with QA in the validation and calibration activities to ensure validated tools, controllers, indicators, hardware, software, and process controllers are operating effectively without engineering faults.
Arranging necessary manpower and spares to rectify the failed equipment.
Coordinating with manufacturers and programmers in completing the issues that require external support.
Reviewing the necessary documents and recommending certification for the operations or activities carried out in the validation and calibration process.
Projects:
Coordinating and following up with external contractors for the installation and commissioning of new equipment, both in the utility and process areas.
Designed a budget in coordination with consultants to build civil engineering structures of up to 30,000 sqft, consisting of basement, ground, and first floors to house manufacturing and testing facilities.
Designed, budgeted, and executed through vendors modular works, including paneling of walls, ceilings, epoxy floorings, etc., for new areas and existing area modifications within a fixed timeline by bringing in various required utilities and contractors to complete without taking a major shutdown.
Executed WFI plant, UF plant installations, loop lines with water distribution skids consisting of various controls for conductivity, pH, and online TOC without shutting down the production activities.
Pure steam installations, designing, costing, and executing pure steam distribution lines with a sloping system to ensure complete drainage of the lines at stoppage and the sanitization process.
Executed the installation and commissioning of lyophilizers, filling line equipment, zonal centrifuges, concentration equipment, ultra freezers, deep freezers, chillers, etc.
Planning regular existing civil structure maintenance activities, scheduling painting, cementing, and waterproofing works all through the year.
Proposed, procured, and executed installations of 500 KVA transformers, 500 KVA soundproof generator sets, synchronizing panels, AMF panels, etc.
Power control centers, motor control centers, IIKV HT structures, centralized UPS, etc.
Planning and overseeing new electrical, piping, and paneling activities in the new and existing areas.
Modification of the existing areas, as per the production/regulatory requirements, as and when needed.
Planning and implementing the latest upgraded automation technology for various production processes.
Documetation:
Reviewing all the PM and BM documents.
Updating the SAP module on complaints, indents, and work orders; creating new equipment; and PM scheduling in the SAP module.
Preparation and reviewing of all the SOPs and RSTs of the Engineering dept.
Preparation of AIA documents for all the operations and equipment of the Engg dept.
Reviewing the Machine History sheets, recommending a future action plan.
Preparing the URS for new machinery, AMC proposals, and service works.
Preparing technical requirements, cost estimates, and action plans for all new machinery procurements, finished setups, etc., for all departments.
Reviewing and recommending qualification documents: FAT, DQ, IQ, OQ, PQ.
Budgets:
Preparation of revenue and capital budgets for the Engineering Department and Plant.
Assisting in the capital budgets and revenue budgets of Production, QC, QA, Admin, etc.
Identifying the materials, services, manpower, and machinery requirements for capital and revenue budgets.
Allotment, technical evaluation, comparison, recommendation of suppliers. Manufacturers and contractors for the projects.
Audits:
Assisting in regulatory audits: WHO, cGMP, CDSCO, PICs.
Indian states and foreign countries: facility audits.
Assisting in the preparation of documents for regulatory audits.
Electrical inspectorate safety audits.
PCB inspections/audits.
As Individual Role:
Attending training programs to carry out internal inspections, TQM activities, and audits.
Carrying out FAT on the equipment.
Assisting Production and QC in their URS documentation.
Educating the subordinates, engineering utility operators, and process equipment operators on the new machine, existing technologies, methods, faults, and problems.
Carrying out interviews for the recruitment of skilled manpower.
Carrying out self-inspection audits, appraising concerned personnel.

Summary

Overview

Work History

Managing Owner

Manager Engineering-HOD

Technician

Education

BE - Electrical And Electronics engineering

DEEE - Electrical and Electronics engineering

ClassXII-HigherSecondarySchool -

Skills

Certification

Timeline

Managing Owner

Manager Engineering-HOD

Technician

BE - Electrical And Electronics engineering

DEEE - Electrical and Electronics engineering

ClassXII-HigherSecondarySchool -

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