Summary
Overview
Work History
Education
Skills
Languages
Hobbies and Interests
Timeline
Generic
Dinesh Suryawanshi

Dinesh Suryawanshi

Bangalore

Summary

Commissioning & Qualification professional with excellent hands-on experiences in Equipment Qualification Fermenter /Bioreactors/Wave Bioreactor/Chromatography/Process Vessels), Equipment Validation (Fermenter /Bioreactors/Chromatography/Process Vessels), Automation Engineering in Bio process Manufacturing Processing & cGMP requirement. Working knowledge in FDA cGMP and 21 CFR part 11 regulations. GAMP software validation guideline, and ISO's regulations. Experience of validation documents (Commissioning/validation plans/Test protocol/IQOQ/FAT/SAT and technical Summary Reports). Hands-on experience on GDP documentation execution. Energetic Field Service Engineer with 7 years background performing repairs, installations and troubleshooting. Committed to providing optimum service support through phone and personal visits. Proficient in investigating and troubleshooting common problems and providing efficient, courteous and professional repair services. Quality-focused Technical Field Service Engineer offering 7 years of field service experience. Detail-oriented and proactive with diligent and focused approach to managing projects, reviewing work and coordinating call responses. Maintains strong internal, supplier and customer relationships for maximum effectiveness. Knowledgeable Field Service Supervisor with top strengths in planning, problem-solving and communication. Skilled in maintaining high customer satisfaction, controlling inventory and providing technical support. Skilled at training and mentoring field service personnel to troubleshoot and correct problems, consistently meeting or exceeding expectations. Well-versed in safety practices and gear, documentation requirements and compliance standards for

Biopharmaceutical industry.

Overview

6
6
years of professional experience

Work History

Commercial Field Service Engineer

Cytiva - India
01.2022 - Current
  • Commissioning and Qualification of Single Use Bioreactors, Wave Bioreactors, Chromatography and Single Use Mixers
  • Execution of IQ OQ Protocol 2000L, 1000L, 500L, 200L, 50L and 10L Single use Bioreactors
  • Execution of IQ OQ Protocol for the Wave Bioreactors followed by 21 CFR part 11
  • Execution of IQ OQ protocol for the Chromatography 6MM (180 l/h), 1 Inch (600 l/h), 2 inch (2000 l/h) and ILC (5000 l/h) followed by 21 CFR part 11
  • Responsible for attending critical breakdown to support the customer during the batch
  • Generation of Quotation for the spare part of the Bioreactors and Chromatography.

Erection & Commissioning Engineer

DD Enterprises - India
05.2019 - 01.2022
  • Experience and In-depth understanding of all System life cycle deliverable from commissioning and Qualification (C&Q)
  • This includes deliverables such as verification plan for FAT, SAT, IQ OQ and Verification Summary report
  • Execution & Providing Engineering support for FAT, SAT, Test procedure, to verify that system performance meet User
  • Requirement specification and quality standard
  • Performed Installation and Qualification of 50KL,6000L,250L,100L,15L Fermenter, CIP station, CIP skid, Process Vessels followed by necessary document execution i.e., FAT, SAT, CSV, and Summary report closure
  • Performed Mechanical & Instrumentation walk down (P&ID, GA, Electrical wiring drawings, System Architecture, weld log)
  • Coordinate with customers for Pre-FAT and FAT and responsible for FAT point closure
  • Execution of FAT along with Customer and Verification of Design Qualification documents
  • Coordinate with the Internal Department till the completion of the Project.

Instrumentation & Automation Engineer (C&Q)

Dyna Biotech - India
08.2017 - 05.2019
  • Experience and In-depth understanding of all System life cycle deliverable from commissioning and Qualification (C&Q)
  • This includes deliverables such as verification plan for FAT, SAT, IQ OQ and Verification Summary report
  • Execution & Providing Engineering support for FAT, SAT, Test procedure, to verify that system performance meet User
  • Requirement specification and quality standard
  • Performed Installation and Qualification of 10000L,5000L,250L,100L,15L Fermenter, CIP station, CIP skid, Process Vessels followed by necessary document execution i.e., FAT, SAT, CSV, and Summary report closure
  • Performed Mechanical & Instrumentation walk down (P&ID, GA, Electrical wiring drawings, System Architecture, weld log)
  • Develop & Execute Fermenter Sequences PHT (Pressure Hold test), ESIP (Empty Sterilization In Place), FSIP (Full Sterilization In Place), Thermosyphon, Media Preparation and Fermentation
  • Experience and In-depth understanding of Process instrument Temperature sensor, Ph, Do2, Co2, MFC, Flowmeter, Pressure sensor, DPT, Load cell, Proximity sensor, Control valve
  • Preparation of Functional Design Specification, Software design Specification and Preparation of I/O list.

Education

Bachelor of Engineering - Electronic & Telecommunication -

Diploma - Electronics & Telecommunication -

Secondary School Certificate -

Skills

  • Installation & Commissioning of Bio Process Equipment (Upstream & DownStream)
  • CQV
  • CSV
  • GDP
  • CGMP
  • GMP
  • P&ID
  • Instrumentation
  • Automation
  • System Architecture
  • ISA-88
  • 21 CFR Part 11
  • Unicorn Software
  • TIA Portal V14
  • Salesforce
  • Computer Software Repair
  • On-Site Support
  • Service Documentation
  • Customer Service Management
  • Troubleshooting and Repair
  • Technical Support
  • Documentation
  • Equipment Installation
  • Managing Projects
  • Calibration
  • Preparing Work Orders
  • Project Management
  • Service Contracts
  • Equipment Installation and Repair
  • Instrumentation Calibration
  • Cross-functional Coordination
  • Time Management
  • Problem Solving

Languages

English
Hindi
Marathi

Hobbies and Interests

  • Reading Books
  • Watching Movies
  • Playing Carrom

Timeline

Commercial Field Service Engineer

Cytiva - India
01.2022 - Current

Erection & Commissioning Engineer

DD Enterprises - India
05.2019 - 01.2022

Instrumentation & Automation Engineer (C&Q)

Dyna Biotech - India
08.2017 - 05.2019

Bachelor of Engineering - Electronic & Telecommunication -

Diploma - Electronics & Telecommunication -

Secondary School Certificate -

Dinesh Suryawanshi