Project Executed & Accomplishment Summary

K.A.Bhimrao Milindhan, M.Tech, M.B.A,

Education Qualifications:
Bachelor of Technology- Chemical Engineering (2001 Batch)
Master of Technology-Industrial Biotechnology (2005 Batch)
Master of Business Administration-Technology Management (2008 Batch)

Work Experience:

14+ Years of experience in Design, Plant engineering, Commissioning and

Qualification of equipments like Biopharma, Clean Utilities systems and
Pharma equipments- Fill Finish systems.

Industries Exposure:

 Pharma Industry
 Bio-Pharma Industry

Skills:

PLC/ PLC Software’s  PLC verification shall be performed as part of

equipment qualification
Protocols  IQ, OQ of BMS (Building Management System) &
EMS (Environmental Management Systems)
Tools/Utilities  BMS/ EMS/ IBMS
 Attended Trainings regarding commissioning and
Trainings importance of Qualification in Pharmaceutical
industry; Industrial Safety training; FIRST AID
training
Regulations  ASME, FDA, ASTM, ISPE, ICH7,8,9 &10.
 Project Details:

M/s. Alkem
laboratories – Biologics Facility Design, Commissioning and Qualification of
Division ( Enzene Process Equipments, Utility and HVAC-AHU systems
Biosciences Ltd- Pune )
Project-Microbial –PTH (Teriparatide) and Mammalian-
Denosu-MAB suite -Pilot scale project to production
Facility-Area layout, area classification, vendor
finalization, equipments ordering, resource allocation,
organizing, planning, direction and execution.
Preparation, review and execution of qualification
protocol and reports related to equipment, system,
utilities and facility for vaccine manufacturing Unit.
Scope Co-ordinated with cross functional team and headed the
validation sphere consists of 14 members for qualification
of Utility systems, HVAC, cGMP facility qualification and
ware house management systems.
FastTrack project successfully completed span of 6
months Brown field project followed by engineering batch
and handed over to User for commercial batch
manufacturing.

Dr.Reddys
Laboratories- Commissioning and Qualification of Equipments
Hyderabad
Preparation , review and execution of qualification
Scope protocol and reports related to equipment, system,
utilities and facility for Cell Culture manufacturing Unit
 Commissioning and Qualification of Bioprocessing
Project Description equipments fermenter, Cross flow filtration
system-TFF, Centralized CIP system, harvesting
 system, Media preparation/ Buffer preparation &
distribution system and product holding system in
new cell culture-CCM2 (RI tux- MAB for oncology)
manufacturing facility.
 Preparation and execution of IQ, OQ, PQ protocols
for Utilities (Water Pretreatment Plant, PW
Generation and distribution system, WFI
Generation and distribution, Pure Steam generation
& Compressed air system distribution system).
 Process Flow Diagram- Played major role in the
process piping design and execution for equipment
inter-connection and distribution for Utilities &
Process Line. Executed 5000 meters piping in the
facility completed within time line as per 60 days’
schedule with respect to Wels inspection,
Baroscopic test, Hydro- Pneumatic Test, NDT test,
Passivation and turn over packages.
 Flow Transfer Panel- Designing & qualification of
process flow transfer panel with respect to product
transfer, addition and CIP/SIP for the systems inter-
connection.
 Cold Storage- Designing, Sizing and capacity
calculation for cold room. IQ,OQ , PQ and
temperature mapping performed.
Project Highlights  Preparation and execution of IQ, OQ, PQ Protocols
 Preparation and execution of Facility Qualification
Protocols.
 Performing Hydro/ Pneumatic Pressure test for
Pipelines.
 Preparation of SOP’s related to Validation
equipments (particle counter, Anemometer etc)
 Preparation and Qualification (IQ, OQ, PQ) of
Process equipments
 Preparation of summary and commissioning report

Responsibilities  Completing the Commissioning and Qualification of

equipments in a given time with all the quality
 attributes and handing over the equipment to the
end user.
 Key member in facility management (BMS/EMS)
and qualification of equipments in new
manufacturing facility at Mylan Hosur
manufacturing facility.
 Key member for Water system and HVAC systems
in regulatory inspection (USFDA, MHRA).
 Conducting internal audits & training programs.
 Identifying areas in lack of quality and taking steps
to correct & prevent the occurrence.

Vaccine Manufacturing
Unit- M/s. Biological-E Ltd Commissioning and Qualification of Equipments
–Hyderabad.
Preparation of validation master plan, URS, DQ,
FAT/SAT, IQ, OQ, PQ as per EU/ FDA guideline and as
Scope
per c-GMP guidelines. Aware of “V”- Validation
MODEL
 Preparation and execution of IQ, OQ, PQ
protocols for Utilities (Water Pretreatment
Plant, PW Generation and distribution system,
WFI Generation and distribution, Pure Steam
Project Description
generation, Compressed air system.)
 Commissioning and Qualification of
equipments in new Biopharmaceutical facility
(Green field Project)
Project Highlights  Preparations of Validation Master Plan (VMP),
Site Master file (SMF).
 Preparation of URS (User Requirement
Specifications), Design Qualification (DQ),
Commissioning Test Plan Protocols. (CTP),
Installation Qualification (IQ) protocols,
Operational Qualification (OQ) protocols,
 Performance Qualification (PQ) protocols for
utilities, HVAC systems and Process
equipments.
 Involved in FAT (Factory Acceptance Test)/ Site
Acceptance Test for Bioprocessing Equipments,
Blast freezer, Glassware washers, Process
equipments for Pharmaceuticals manufacturing
facilities.
 Scheduled the project and performed monthly
audits and ensured that the project timeline
was maintained.
Responsibilities  Key member in Conducting FAT (Factory
Acceptance Test), SAT (Site Acceptance Test)
for Equipments, Commissioning of equipments,
Preparation of Qualification Protocols
(Equipments, Facility, Process, Cleaning).
 Conducting internal audits & training programs.
 Identifying areas in lack of quality and taking
steps to correct & prevent the occurrence.
 Given Training on Safety Measurements & First
AID training to the team members.

Biologics –Dr.Reddys
Plant Engineering
Lab-Hyderabad.
Knowldge of handling QMS like CAPA , Change control,
Scope deviation and investigation.sholud have knowldge of
Risk management as per ICH Q9 guideline

 Having good knowledge about ASME-BPE section-

VIII- Division-I standards to develop the design of
Description equipment and components standards for use in
the biopharmaceutical industry of bioprocessing
equipments.
 ASTM E 2500 adherence to vendor selection,
 equipment selection, qualification and
documentation
 ISPE guidelines of pharmaceutical Utility systems
commissioning and qualification of water systems
and steam systems.
 Adherence with ICH- International Conference on
Harmonization in Deviation management, FMEA
in the context of ICH Q9/Q10 and adequate
knowledge on FDA’s new process equipment
validation guidelines.
 Good knowledge about c-GMP requirements,
Automation standards and compliance with
recipe based, operations through PLC, HMI and
SCADA -21 CFR part 11 compliant control systems
and CFR 210 & 211 for biopharmaceutical
industry.

Project Highlights  Handling QMS (Change Control, CAPA, Incidents)

activities related to Validation
 Initiation and closure of Planned Deviations and
unplanned deviations.
 Conducting investigations for Incidents and
deviations occurred during Qualification.
 Along with user departments initiation of Change
controls for facility modifications, equipment
modifications, Utilities modification etc.
 Verification of QRM (Quality Risk management)
during qualification.
 Conducting internal audits.
 Conducting trainings related to Qualification.
 Identifying areas in lack of quality and taking
steps to correct & prevent the occurrence.
Responsibilities Key member for QMS related to Validation Indian FDA,
WHO and Internal Audit of cross functional.
Cell Culture
Manufacturing – MAB &
Multi product Facility Management
Manufacturing Facility (
Oncology)
Having knowledge on PLC and SCADA validation of
Scope
Bioprocessing equipment as per GAMP5 guidelines.
Commissioning and Qualification of equipments in new
Project Description
Biopharmaceutical facility.
Project Highlights Preparation and Execution of Qualification protocols
for Building Management System (BMS) protocols.
Preparation and execution of Computational system
Validation Protocols (Distributed control systems (DCS),
BMS, Thermo lab Software,Yokagawa data logger
Software)
Responsibilities To Qualify the BMS in a given time with all quality
attributes and hand over to the end user.

LCM & SDLC (

Life cycle management & System Design Life Cycle
Engineering
Management
Maintenance)
Calibrations of instruments/components are involved in
Scope
Bio-Process equipment / system/ utility.
Preparation, Review and approval of calibration of
Description
instruments in the entire facility.
Project Highlights  Verification of Calibration of components
involved in Utilities, HVAC systems, equipments.
Responsibilities  Ensuring that Components in the equipments are
calibrated. Identifying the components in the
equipment whether it is Critical or non critical.
Assisting in preparation of the Calibration master
list.
 Eg- pH, temperature, pressure, Conductivity,
 Dissolved Oxygen sensors cum transmitters,
Pressure gauges and weighing systems/ load
cells.
 Complied to Life Cycle Management Schedule
(PM, Calibration and Revalidation)
 Critical spare parts list as per the critical
equipments identified for all critical / major
equipment’s
 Coordination for Critical / major equipment’s
maintenance happening through Engineering
maintenance team service providers with AMC /
service call basis.
 Maintaining the Equipment list, Critical spare
parts list for all critical equipment’s.
 Regular breakdown analysis & weekly PM and
Calibration schedule performance.
 Assessment of PM activities, frequency and SOP’s
are in progress.