Summary
Overview
Work History
Education
Skills
Certification
Applicationskills
Rewardrecognition
Projectshandled
Internshiptraining
Personal Information
Hobbies and Interests
Languages
Timeline
Generic

Manikanta Kotni

Hyderabad

Summary

**Project Engineer in Sterile Injectable and Biologics Division**

My objective is to become a successful professional in the field of Engineering, contributing to an innovative and competitive world. I am eager to work as a key player in a challenging and creative environment. With extensive experience in the pharmaceutical industry, particularly in the Sterile Injectable and Biologics Division, I aim to further my career in a Pharma Engineering company. Here, I seek to engage in complex projects, enhance my skills, and deepen my understanding of design concepts.

As a reliable Plant Engineer with many years of experience in facilities management, I am known for designing optimally efficient operational frameworks while prioritizing employee health and well-being. I am dedicated to maintaining safe, productive work environments that not only meet but exceed business goals, while also fostering the growth and development of personnel.

Overview

10
10
years of professional experience
1
1
Certification

Work History

PLANT ENGINEER

Dr. Reddy's Laboratories Limited, Biologics Division
Hyderabad
10.2019 - Current
  • URS, FAT, SAT, Installation, modification, Upgradation, commissioning and qualification activities of New Equipment and Existing Equipment's
  • Preparation of Qualification Protocols and Impact Assessments like CLIA, QRA, RTM, Facility Risk Assessment, SRV
  • Defining Project Scope and Deliverables
  • Involved in Process Safety management -Pre-Start UP safety Reviews, Walk down, What If analysis, HIRA for Equipment's
  • QMS Elements Change Control, Incident Management, RCA, CAPA, SOP Preparation, Protocols Preparation and Reports generation
  • Hands on experience in Design review of the equipment's Utility, pipeline and P&ID's, specifying equipment sizes, Pipeline sizes, Instrument locations, types, controls
  • Ensuring Compliance as per USFDA EU GMP, GAMP, GEP, GXP, 21 CFR, ISPE and regulatory guidelines ASTM E2500
  • Effective Coordination with CFTs, Stakeholders, verbal and written communication skills, Project Coordination and Management, Execute C&Q activities with multiple stakeholders like (Engineering responsible, Design consultant, Vendor's, and QA) of the project organization
  • Maintenance and troubleshoot, Planning & Scheduling of PM's for Process Equipment's like Vial Filling line, PFS Filling line, Autoclave, Parts washer, Lyophilizer, Packing & Labelling line, Cold Rooms & Deep Freezers, USP, DSP Equipment, Fermenters, CIP SKID and Pressure Vessel
  • PFS Assembly and injector device equipment's and PID Valves of Equipment
  • KAIZEN, 5S, TPM for continuous improvement activities.

Assistant Officer

Pfizer Healthcare India Private Limited, Visakhapatnam
06.2014 - 09.2019
  • Operation & maintenance of (IMA Life Vial Filling Line, BOSCH Ampoule Filling Line, FEDEGARI Steam Sterilizer
  • Investigation of Breakdown route cause analysis
  • Equipment Qualifications IQ, OQ, PQ
  • Incident, Change Control and CAPA Closure
  • Participate in the internal Corporate and external regulatory and Non-Regulatory Audits
  • Always ensuring equipment maintained in cGMP Standards
  • Plan and execute the Preventive maintenance program
  • Trouble shooting and rectify equipment breakdowns in shortest possible time.

Education

BTECH- Mechanical Engineering -

SAI GANAPATHI ENGINEERING (JNTU-K) Regular
ANDHRA PRADESH
07.2017

DIPLOMA-Mechanical Engineering -

SAI GANAPATHI POLYTECHNIC (SBTET)
ANDHRA PRADESH
05.2014

SSC -

CHAITANYA VIDYALAYAM (SSC)
ANDHRA PRADESH

Skills

  • AUTOCAD
  • CATIA
  • MICROSOFT OFFICE
  • SAP [PLANT MAINTENNCE]
  • AMPS [MES- ROCKWELL AUTOMATION
  • DOC HUB
  • E Val [VALlIDATION]

Certification

  • Process Safety management (NEBOSH)
  • Project Management Foundations Communications (Linked IN Learning)

Applicationskills

  • MICROSOFT OFFICE
  • SAP [PLANT MAINTENNCE]
  • AMPS [MES- ROCKWELL AUTOMATION
  • DOC HUB
  • E VAL
  • EAMS

Rewardrecognition

  • Manufacturing Excellence award 2020
  • BEST RCA Award 2021

Projectshandled

  • PROJECT PHOENIX: Increasing OEE of Fill Finish Facility. Upgradation of Vial Filling Line to 21 CFR Compliance. Commissioning & Qualification of Steam Sterilizer and Part Washer and CIP system.
  • WAREHOUSE EXPANSION: Commissioning & Qualification of DE Dusting Tunnel. Installation of New Cold Rooms
  • New Fill Finish Facility: Design Review and FAT Execution for DDE Formulation Vessels, CIP Skid and Steam Sterilizer, VHP Pass Box, Part Washer and Sterline PFS line, LAF & Pass boxes. FAT for Syntegon packing lines
  • Facility Modification: Facility Modification and Qualification, Installation New Equipment for Process Flow change, Business improvement which enables to increase number of production batches.

Internshiptraining

RINL VIZAG STEEL PLANT, Overview of Steel Manufacturing, Steel Melt Shop Operation and Maintenance works

Personal Information

  • Father's Name: VENKATESWARA RAO[LATE]
  • Mother's Name: LAKSHMI
  • Title: Housewife
  • Date of Birth: 09/25/95
  • Marital Status: Married

Hobbies and Interests

  • Travelling
  • Movies
  • Cooking
  • Reading Books

Languages

English
First Language
Hindi
Proficient
C2
Telugu
Proficient
C2

Timeline

PLANT ENGINEER

Dr. Reddy's Laboratories Limited, Biologics Division
10.2019 - Current

Assistant Officer

Pfizer Healthcare India Private Limited, Visakhapatnam
06.2014 - 09.2019

BTECH- Mechanical Engineering -

SAI GANAPATHI ENGINEERING (JNTU-K) Regular

DIPLOMA-Mechanical Engineering -

SAI GANAPATHI POLYTECHNIC (SBTET)

SSC -

CHAITANYA VIDYALAYAM (SSC)

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Manikanta Kotni