Maintenance professional with 14+ years of experience in lyophilizer systems, preventive maintenance, equipment validation, and GMP/cGMP compliance in pharmaceutical and biotech industries. Seeking to leverage technical expertise and process improvement skills in a regulated manufacturing environment.
Overview
15
15
years of professional experience
Work History
Jr. Executive – Maintenance
Biological E Limited – Vaccine Division
07.2022 - Current
Maintaining Edwards manual and Truking automatic lyophilizers.
Executed IQ/OQ/PQ protocols and coordinated lyophilizer batch start-up activities.
Developed SOPs, preventive maintenance schedules, and equipment qualification documents.
Performed condition-based monitoring and calibration as per schedule.
Sr. Technical Assistant – Maintenance
Aurobindo Pharma Ltd (Wytells Pharma Pvt Ltd)
03.2019 - 07.2022
Handled Tofflon lyophilizers with automatic RBR system.
Led preventive maintenance planning and QMS activities including CAPA and change controls.
Coordinated OEM vendor AMC and procurement of spares.
Implemented 5S practices and supported computer system validation.
Jr. Executive – Maintenance
Bharat Biotech International
02.2018 - 03.2019
Maintained Tofflon & Martin Christ lyophilizers; performed equipment validation.
Managed SAP-based material indenting and preventive maintenance.
Prepared and executed equipment qualification protocols.
Asst. Officer – Maintenance
Natco Pharma – Oncology Block
06.2014 - 01.2018
Operated and maintained lyophilizers, vial washers, and compounding vessels.
Performed CIP/SIP cycles, HVAC validation, and autoclave operations.
Led preventive maintenance and troubleshooting of manufacturing equipment.
Service Engineer
Lyophilization Systems Inc. (LSI)
06.2011 - 06.2013
Assembled lyophilizer systems, SCADA/PLC panels, and refrigeration systems.
Conducted FAT/SAT validation and troubleshooting during lyophilization.
Executed IQ/OQ/PQ protocols and preventive maintenance.
Education
Diploma in Electrical & Electronics Engineering -
TRR College of Technology
ITI in Electrical -
H.E.H The Nizam & Alladin Institute
S.S.C -
Board of Secondary Education
Skills
Lyophilizer Operation & Troubleshooting
Preventive Maintenance
CIP/SIP
SCADA/PLC Systems
GMP/cGMP Compliance
QMS
CAPA
Change Control
SAP (MM)
AutoCAD
Windows OS
Timeline
Jr. Executive – Maintenance
Biological E Limited – Vaccine Division
07.2022 - Current
Sr. Technical Assistant – Maintenance
Aurobindo Pharma Ltd (Wytells Pharma Pvt Ltd)
03.2019 - 07.2022
Jr. Executive – Maintenance
Bharat Biotech International
02.2018 - 03.2019
Asst. Officer – Maintenance
Natco Pharma – Oncology Block
06.2014 - 01.2018
Service Engineer
Lyophilization Systems Inc. (LSI)
06.2011 - 06.2013
Diploma in Electrical & Electronics Engineering -
TRR College of Technology
ITI in Electrical -
H.E.H The Nizam & Alladin Institute
S.S.C -
Board of Secondary Education
Disclaimer
I do hereby declare that information given above is true and complete to the best of my knowledge and belief.