Ashishkumar Patel

• Managed and maintained facility equipments like Purified Water System (PWS-BWT), Rees -Temperature and Humidity measurement system, Metasys-Software for Roof-Top Units, Boilers, Dryers, Compressed Air Systems etc.
• Managed and maintained the equipments which are used for Manufacturing (Tanks, Mixers, Pumps, Powder Transfer systems etc.) and Packaging (Bottle unscrambler, Bottle filler, Air Rinser, Capper, Induction sealer, Labeler, Top-sorter, Neck bender , Heat Tunnel, Case packer, Tape Sealer etc.) for the production.
• Supervised maintenance staff and facility cleaning staff.
• Improved facility efficiency by conducting regular inspections and implementing necessary upgrades.
• Scheduling Preventive Maintenance (PM) and Calibration for all the equipments. Communicate with vendors for doing calibration of equipment, making service contract for the equipment, for doing annual inspection etc.
• Performing and helping staff for PM of all the equipments as per schedule by following SOP.
• Performing In-house calibration of different equipments like pressure gauges, temperature gauges, speed measurement of pump, mixer and motor, scale etc.
• Developing SOP for operating the equipment, PM calibration, facility cleaning, power outage etc.
• Troubleshooting of equipment during batch is running in Manufacturing and Packaging department.
• Following up the facility drawings for tracing out the problems.
• Maintaining the data for Water , Waste-water, Room differential pressure, sprinkler, fire extinguishers etc. regularly.
• Maintaining Facility Asset Register and Master Equipment List with consideration of Equipment ID number, Onboarding process, Equipment release and Decommissioning procedure.
• Executing Installation Qualification/Operational Qualification/ Performance Qualification Protocols for qualification of any equipment.

· Troubleshoot and service of high-tech Flexo Machines like Digicon Series new etc. which are used to make Labels burnished for the pharmaceutical industries.

· Operate the above-mentioned Digicon Flexo machines independently and give a good qualitative Production with high efficiency by following WOMS System. Also able to do troubleshooting and routine maintenance of the above-mentioned Digicon Flexo machines.

· Able to do Image registration, Die and Plate set up for labels, Synchronized all the units Slitter, flexo unit, image registration unit, heater etc.

· Able to troubleshoot of the same and also to do PM on weekly of Digicon Series equipment.

· Hands-on experience in supporting ongoing operations by performing and coordinating maintenance, troubleshooting, start-up, commissioning as well as qualification of various equipment, instruments like Filler (All fill, Caps all, syringe & micro dosage), Capper(Kalish & Kinex), cap tighter, sealer (KBiosciences), inserter, Labeler (Weber), auto cartoner (Bivans), High tech ink printer (Keyense & HAPA), Bander (ba32)etc. that supports pharmaceutical production operations for various lines like Gel line, Liquid bottle filling line(National), aerosol line, Blister packaging line (Blipack), Tablet packaging line, Klockner, tube filling system, tablet filling system etc.

· Doing PM (Preventive Maintenance) & Troubleshooting of different instruments and machines which are used for production of pharmaceutical products.

· Coordinate preventive maintenance, commissioning, qualification and validation activities, troubleshooting, etc. as per Client’s procedures as well as guidelines and provide engineering and technical services by planning, coordinating as well as scheduling their execution.

· Process preventive maintenance orders (PMOs), Work Orders (WOs) as per schedule.

· Set up the production line with many instruments as per the batch record.

· Able to do changeover, maintain the production line in running of batch and also troubleshoot in case of need.

· Maintain the documentation for troubleshooting, usage, PMO & WO and also maintaining the log books.

· Operate and Troubleshoot of high-tech Digital Laser Printers like RICOH, IGEN and KONICA MINOLTA 14000S.

· Operate the above-mentioned Digital laser printer independently and give a good qualitative Production with high efficiency by following WOMS System.. Also able to do troubleshooting and routine maintenance of the above-mentioned digital printers.

· Provide engineering and technical services to ensure compliant operation of processing equipment needs on a sustainable basis.

· Coordinate preventive maintenance, commissioning, qualification and validation activities, troubleshooting, etc. as per Client’s procedures as well as guidelines and provide engineering and technical services by planning, coordinating as well as scheduling their execution.

· Use computerized maintenance management system (CMMS) for laboratory instruments as well as processing equipment to process preventive maintenance orders (PMOs), Work Orders (WOs),

· Spare parts, etc. Gather and enter relevant data to build equipment/instrument asset records, generate history reports, track KPIs and manage test standards.

· Assist in risk assessments, change controls, protocols – including their executions, resolution of field issues.

· Hands-on experience in supporting ongoing operations by performing and coordinating maintenance, troubleshooting, start-up, commissioning as well as qualification of various equipment, instruments like Powder Filler, Mixer, Autoclaves, Elustick production unit, Heating and robitic welding system, UV inspection system, pouching and packaging system etc. that supports pharmaceutical operations for production of Eluring (Birth control product), Tablet press, Capsule packaging line etc.

· Do calibration and Preventive Maintenance of analytical instruments like HPLC, GC, UV-VIS Spectrometer etc.

· Initiate Change Controls and Corrective Action / Preventive Action (CAPA) as per requirements.

· Verify and follow-up to ensure that all required pre-requisites as well as technical documents for the equipment are available in a timely manner.

· Reviewed and updated SOPs and lockout/tagout (LOTO) procedures

· Developed Standard Operating Procedures (SOP’s) for processing equipment

· Supported equipment cleaning and implementation of CAPA.

· Provide engineering and technical support services to TPSI’s internal projects as well as BioPharma customers to supplement their staff in supporting projects and ongoing operations.

· Completed TPSI’s specific internal training in:

Ø GMP, GDP, GAMP, QRM, Criticality and Risk assessment, Change controls, CFR Part-11 compliance Preparation of SOPs, PMOs, WOs, SWIs, URS, FRS, execution of IOQ, processing of deviations and reports.

Ø Review of completed projects for folder security configurations, Data/software archival, backup, retrieval, commissioning, decommissioning, comparing files and traceability of data, time stamping and audit trail, alarm and event table field configurations, etc.

Orientation – Computer System Platforms that support Bio-Pharma operations such as TrackWise for investigations, CAPA, etc.; LIMS for QC laboratories, Empower for HPLCs, ProCAL for calibration, etc