1. NANIBABU TANGELLA
Commissioning and Qualification Engineer
Nanibabu is an experienced validation professional with Master’s Degree in Biotechnology and 5 years of
Sterile Biotech industrial experience. He specializes in Quality Assurance in the areas of Equipment validation,
Utilities validation (HVAC System, Water System, Pure Steam Generation System, and Compressed Air
System.), Cleaning Validation, CIP & SIP Validation, Shipment Validation, Facility Validation (Quality control
dept., Fill & Finish dept.), Media fill validation and Computer system validation.
KEY COMPETENCIES
Equipment Commissioning,
Qualification & Validation (Bio
processing equipment)
IPQA (In Process Quality Assurance)
Utilities Validation (HVAC,
Compressed air, Water, and Pure
Steam)
Cleaning Validation Aseptic Process Validation CIP & SIP Validation
Facility Validation Risk Assessment
EXPERIENCE
Pfizer (CAI)
Kuala Lumpur,
Malaysia
Commissioning and Qualification Engineer
Duration of Assignment: Ongoing Since December 2015
Commissioning and Qualification (IQ, OQ) activities for Solution preparation line of
Pfizer company (India):
 Soy bean vessel (2000 Liters)
 Dispersion vessel (1200 Liters)
 Batch vessel (2000 Liters)
 Transfer panels
 Homogenizer
SHANTHA
BIOTECHNICS Ltd. (A
SANOFI COMPANY)
Hyderabad, India
QA Validation Officer
Duration of Assignment: 2 Years
 Performed Qualification (IQ, OQ & PQ) activities for the following Equipment:
- Steam Sterilizer and Dry Heat Sterilizer
- Vial Washing Machine and Depyrogenating Tunnel
- Fermentor and Blending vessel
- Cold Room and Deep Freezer
- Incubator and Stability Chambers
- Ultra-low Temperature Freezer
- Air flow units (e.g., LAFU, Dynamic pass box and Dynamic Garment Storage
cubicles etc.,) and Bio safety cabinets
 Performed Qualification activities for the following Utilities:
- HVAC System
- Water System
- Pure Steam Generation System
- Compressed air system
 Validation:
- Cleaning Validation
- CIP & SIP Validation

2. NANIBABU TANGELLA
Commissioning and Qualification Engineer
- Shipment Validation
- Facility Validation (Quality control dept., Fill & Finish dept.)
- Media fill validation
- Computer system validation
 Equipment handled:
- Kaye Validator (GE) (For thermal mapping, sensors calibration activities)
- Yokogawa Data logger
- Eurotherm Data logger
 IPQA Activities:
- In process quality checks during the batch production
- Utility checks during Batch production
- Maintained and verified all record sheets/Log books related to the Biotech
manufacturing
- Reviewed all GMP related documents e.g. SOPs and Protocols
 Documentation:
- Prepared and reviewed Installation, Operational and Performance
Qualification protocols and reports
- Planned and Executed Revalidations and Requalification as per the schedule
- Coordinated with vendors and user departments for commissioning of
equipments and its documentation
- Handled Change Controls, Deviations, Investigations and its effective
implementation of CAPA (Corrective Action and Preventive Action)
- Coordinated with engineering in calibration and preventive maintenance
activities
- Handled Risk Assessments, Failure Mode Effective Analysis (FMEA)
Kemwell Biopharma
Pvt. Ltd.
Bangalore, India
Jr. Executive
Duration of Assignment: 1 Year + 9 Months
 Executed Unidirectional Units (LAFU, BSC, Pass boxes etc.) IQ, OQ & PQ
 Executed Thermal Equipments (Vial Washing Machine, Depyrogenating Tunnel,
Steam sterilizer (Fedigari autoclaves), Fermentor and Blending vessel, Cold Room,
Deep Freezer, Incubator and Stability Chambers etc.) IQ, OQ & PQ.
 Prepared Risk Assessments
 Executed Area Qualification, aseptic media fills validations
 Exposed on Air Handling Units
 Reviewed IQ, OQ, PQ documents for all initial installed equipments in plant as per
design specifications
 Prepared User Requirement Specification (URS) for Equipment’s related QA
Validation
 Reviewed area qualification protocols and monitoring data
 Reviewed Environmental monitoring data and trends preparation
 Supported and Reviewed the DQ, IQ, OQ, and PQ protocols from the user
department
 Reviewed validation/ Protocols and Reports
 Developed and tested Packaging Processes using DoE
 Processes Mapping and Analysis (e.g. FMEA)

3. NANIBABU TANGELLA
Commissioning and Qualification Engineer
 Worked according GxP
 Pharmaceutical Processes and Equipment Validation
Ranbaxy
Laboratories Ltd.
Bangalore, India
QA Trainee
Duration of Assignment: 1 Year + 3 Months
 Supported Unidirectional Units (LAFU, Bio safety cabinets, Pass boxes etc.) IQ, OQ
& PQ.
 Assigned & Updated equipment ID. No., qualification document numbers.
 Executed equipment qualification.
 Supported the execution of Area Qualification.
 Reviewed IQ, OQ, PQ documents for all initial installed equipments in plant as per
design specifications.
 Participated in Internal and External trainings.
 Participated in self-inspection and external inspections.
 Reviewed Environmental monitoring data and trends preparation.
 Supported and Reviewed the DQ, IQ, OQ, and PQ protocols from the user
department.
 Made a schedule for Performance verification of the equipments.
HISTORY & TRAINING
History:  MSc, Biotechnology, Andhra University (2010)
 BSc, Chemistry, Botany & Zoology, Andhra University (2007)
 Commissioning Agents, Commissioning and Qualification Engineer (2015-Present)
Training:  Bio safety and Bio security at Ranbaxy Ltd., Bangalore, conducted by World
Health Trust
 GMP Documentation and Validation at Insight Systems Inc., Mumbai.
 Basic Fire Safety and Emergency Preparedness (From USHA Fire Safety
Equipment’s (P) LTD.)