Ravindra Kumar Sisodia
Sr. Director Engineering (Engineering Head-Drug Product). Injectable regulatory plant
- Role
- Head of Engineering Department at Biocon Biologics
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Ravindra Kumar Sisodia
Profile: 18+ years of experinces as SME in Projects & Engineering/Instrumentation/Automation/Calibration/CSVExperience & Expertise in Pharmaceutical / Biopharmaceutical Industries.Key Roles & responsibilities-Along with the main role of Engineering, I handled various other functions like Projects, Validations/Qualifications, Automation, Instrumentation and Calibration. I have been into Engineering role since the beginning of my career. I started as Engineering Trainee with GSP ELECTRONICS. Afterwards moved into higher roles at Accord Technology and Bausch & Stroebel /Food & Pharma for India as well as overseas Customers. The Engineering role involved various aspects – All critical processing equipment like Vial line, PFS line, Ampoue line, Cartridges line, Isolator, Lyophilizers, Closer processing unit, Autoclaves, inspection & leak detection machine etc. and -Black Utility Equipments, Clean Utility Equipments, HVAC, Process Equipment Maintenance, Preventive Maintenance, Breakdown Maintenance, Statutory Compliance, GMP Compliance, Inventory Management, GMP Documentation – SOPs, CCF, Deviations, CAPA etc.As part of Audit Compliance I played lead role from Engineering function in handling Audits by various international regulators, customers & business partners. The major audits faced are USFDA, MHRA, ANVISA, WHO GMP, GCC. This activity involved checking day-to-day compliance to Engineering Systems. Validation/Qualifications:I anchored this function at Bausch & Stroebel, Amneal & Serum Institute. It involved activities starting from URS till PQ completion. The major role played from Engineering design perspective at the start of project, Software FAT, Machine FAT & Vessel inspection during the project and IQ, OQ and PQ at site. Working with Amneal Pharma & Serum Institute, I have completed successfully qualifications of all the equipments for PD, QC, WH, DS, DP and Engineering. The major role played from the basic design, FAT till PQ completion. I did 3 major projects (Vial line with Isolator, Ampoule line with Seidenader Inspection machine & Bosch high speed filling line with closer Processing unit at Serum Institute of India Ltd.
Experience
Head of Engineering Department
Dec 2024 — Present · Bengaluru, IN
Responsible for B1 & B2 block Drug Product.
Education
Graduate engineering in electronics from Government Institute
Bachelor's degree, Electronic & Telecommunication with 75.57%
New Delhi
Engineering Diploma from Government Institute, Delhi, Electronics Engineering
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