Rajesh Surada
Deputy Manager, Biotechnology, Upstream Cell culture Manufacturing, MSAT, Process Validation, Qualification, Quality Management System, Computer System Validation & Computer System Assurance, ISO 9001:2015&ISO 13485:2016
Hyderabad
11+ years of work experience
Oct 20221 yr 10 mosJul 2024
India
• Executed DeltaV-controlled automated single-use bioreactor batches in validated GMP environment
• Monitored SCADA alarms, interlocks, and process trends during batch execution
• Lead process validation and CPV trending for automated batches
• Managed deviations, CAPA, Gap and Risk assessments related to process and facility
• Supported change control activities impacting DeltaV-controlled automated workflows
• Collaborated with QA and CSV teams for validation of eQMS systems, including documentation review and execution support
Sep 20201 yr 7 mosMar 2022
Bengaluru, Karnataka, India
• Executed 2000L stainless steel bioreactor campaigns using Wonderware automation systems
• Monitored CPP trends using historian data and supported process optimization
• Supported equipment qualification and validation documentation review
• Managed deviation investigations and Change control activities
• Delivered training through ComplianceWire eLMS platform
Dec 20181 yr 9 mosAug 2020
Greater Bengaluru Area
• Executed automated seed train and production bioreactor operations using DeltaV systems.
• Managed deviation investigations and change control using TrackWise eQMS
• Collaborated with CSV teams on validation documentation and system compliance activities
Sep 20144 yrs 4 mosDec 2018
Hyderabad, Telangana, India
• Executed upstream manufacturing using automated stainless-steel bioreactors
• Monitored critical process parameters (pH, DO, gas flow) using PI historian
• Supported process validation and SAP-based batch documentation activities
• Authored SOPs and BMRs aligned with GMP requirements
• Participated in equipment qualification (IQ/OQ/PQ) and validation activities
Oct 20121 yr 11 mosAug 2014
On-site
• Authored and executed IQ/OQ/PQ protocols for upstream process equipment
• Prepared URS, RTM, and validation documentation for DS facility equipment
• Participated in FAT/SAT and media simulation activities for upstream readiness
Education
Master's degree, Biotechnology
Sathyabama University Dental College And Hospital
Bachelor's degree, Biotechnology
kl university
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