R. RAKISH KUMAR
Commissioning and Qualification Engineer
Bangalore
Summary
Accomplished professional with 18+ years of experience in bio-pharmaceutical and pharmaceutical projects. Expertise in project lifecycle execution, installation, commissioning (FAT & SAT), and qualification activities. Adept at planning, execution, design, instrumentation, automation, vendor coordination, and quality testing of biotech equipment. Experienced with team leadership, strategic planning, and operational management. Utilizes effective communication and organizational skills to drive project success. Track record of fostering productive work environments and achieving set goals.
Overview
21
21
years of professional experience
6
6
years of post-secondary education
4
4
Languages
Work History
Manager – Installation, Commissioning, Validation, Qualification & Project QA
Sartorius Stedim (India) Pvt. Ltd.
BANGALORE
03.2006 - Current
- Led qualification and validation of equipment, utilities, and processes
- Developed Master Validation Plans, SOPs, Risk Assessments, and Quality Documents
- Managed system qualification activities during PRE-FAT, FAT, SAT, IQ & OQ >200 Biopharma equipment's
- Ensured compliance with ISPE, EU, and ICH guidelines
- Coordinated with project teams for documentation and compliance
- Oversaw deviation investigations and implemented CAPA
- Managed engineering audits, facility maintenance, and change control
- Accomplished multiple tasks within established timeframes.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Maintained professional, organized, and safe environment for employees and patrons.
- Built high-performing teams through effective recruitment, onboarding, and talent development initiatives.
Installation & Service Engineer
Scigenics India Pvt. Ltd.
Chennai
01.2004 - 01.2006
- Commissioned bioreactors/fermenters for pharmaceutical applications
- Calibrated sensors and transmitters (Temperature, pH, Conductivity, etc.)
- Executed PLC wiring, troubleshooting, and SCADA integration
Education
Executive Business Management Program -
Indo-German Training Centre
Mumbai 02.2022 - 05.2023
MBA - Project Management
Alagappa University
Karaikudi 04.2010 - 04.2012
Diploma in Electronics & Instrumentation - Electronics & Instrumentation
Madras University
Chennai 05.1995 - 03.1998
Skills
- Commissioning & qualification of biotech systems
- Leadership
- Budget tracking
Team leadership
Decision-making
Strategic planning
Time management
Workforce management
Cross-functional teamwork
Documentation and reporting
Project planning
Complex Problem-solving
Key Projects Handled
Reliance Life Sciences, Dr. Reddy’s, Biocon, Panacea Biotec, Zydus Biologics, Intas Pharma, Lupin Biopharma, Syngene International, HANMI Pharma, DONGA, Green Cross, MERCK, NHRI, Adimmune, EirGenix, Celgen, Sinomab, Genescience, Pfizer, Samsung, HIPRA, Kocak Pharma, CIGB, CIMAB, Zoetis, MSD Pharma
Instrumentation And Automation Skills
- Calibration of temperature, pH, conductivity, turbidity, and level sensors.
- Commissioning of IP-Control panels, VFD controllers, mass flow controllers.
Disclaimer
I hereby declare that the information provided is true to the best of my knowledge.
Personal Information
- Passport Number: Y9319663
- Date of Birth: 04/07/78
- Nationality: Indian
Timeline
Executive Business Management Program -
Indo-German Training Centre
02.2022 - 05.2023
MBA - Project Management
Alagappa University
04.2010 - 04.2012
Manager – Installation, Commissioning, Validation, Qualification & Project QA
Sartorius Stedim (India) Pvt. Ltd.
03.2006 - Current
Installation & Service Engineer
Scigenics India Pvt. Ltd.
01.2004 - 01.2006
Diploma in Electronics & Instrumentation - Electronics & Instrumentation
Madras University
05.1995 - 03.1998
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