Experience

BiOZEEN

• India
• Biotechnology
• 200 - 300 Employee

• Manager Biozeen Regulatory Services

  • Sep 2012 - Present

  1) Over all operation and maintenance of BRS lab , Marketing, sales, planning ,Procurement, Customer communication , handling and responding to all FDA querys . Solution provider for all critical problems both internal and external challenges 2) Core member in Designing of Bacterial challenge testing jig from concept to working model including validation of entire unit. Patent Pending. 3) Found cost effective solution for Design flaw in HVAC unit - Class C cleaning room which had temperature related issue. 4) Part of Employee Health & Safety (EHS) TEAM in implementing safety measures in Lab and Utility 5) Revived a WFI unit and its Cooling tower lying un-used, later achieved all required parameter 6) Modified lab layout for ease of operation 7) Part of the TEAM that designed and qualified “21 CFR part 11 Automated Filtration Skid 8)Sound knowledge with respect to clean room working and validation 9) Sound knowledge in electrical circuit designs, Calculation, and implementation 10) Automated many standalone unit and Connected to LAN for remote handling Show less



Merck Life Science

• Germany
• Biotechnology Research
• 700 & Above Employee

• Senior Engineer

  • Apr 2007 - Sep 2012

  • Was responsible for Maintenance activities related to Access Lab, from planning of Calibration, validation, Spares, Repair and maintenance with 100% working efficiency • Good at Planning and organizing all planned activities without affect /hindering productivity of labs, • Awarded with Lighting award for reviving a instrument • Handle Asset procurement for Labs instrument from HO – through Software approval. • Modified a control panel for Explosive proof oven – 6 KW to avoided data loss by incorporating just 500 watt UPS to the system • Successful in network connection of instrument even the OEM / agency were unable to do it. • Designed a Reconstitution vessel for 2 to 8 temperature with available resources in lab. • Designed working concept for alarm unit for over shoot temperature for old cool room as per the audit requirement • Revived IT2+ (automated Integrity Tester), an Out-dated machine, by sourcing critical component from abroad and also creating a spare board for the same. • Modified IT2 pneumatic modules which had frequent leak issues during normal working – with innovative solution. This issue was sort out completely one for all. • Handling CAPA, deviations, Change controls, qualifications and Validations Show less



Biocon

• India
• Biotechnology Research
• 700 & Above Employee

• Junior Executive

  • Jul 2003 - Mar 2007

  Junior Executive Engineer 1) Introduced Concept of Automation of AHU in cost effective way. 2) Introduction of Common Alarm point to the control room of different department - Remote Critical shaker room 3) Validation Specialist of Critical equipment's like - 85 freezer, Autoclave , Clean rooms etc 4) Small innovation idea to the increase the efficiency of water bath, Cyclo mixer etc 5) Coordinator with vendors for Lab Modification 6) Specialist in calibration of digital controller 7) Over all handling Compliance/ Audits /Certifications –ISO 8) Maintain all critical Production Autoclave 9) Design the Alarm ckt to a shaker incubator when belt driven motor unit fails Show less