Ritesh Patel Email & Phone Number

Exton, Pa

• Writing/executing IQ/OQ/PQ protocols for all sanitary process equipment’s, systems, clean utilities, GMP warehouse and CTU’s.• Extensive hands-on experience for developing new cleaning validation program for manual (COP) and automated cleaning (CIP), Autoclave Sterilization Cycle Design for liquid/dry goods load, and temperature mapping of Controlled Temperature Units.• Expert in writing and executing validation protocols (URS/DQ/FS/FAT/SAT/IQ/OQ/PQ) and managing Validation Project Lifecycle.• Support the commissioning, startup, and routine operation of support equipment in a cGMP Pilot Plant to start new cGMP Pilot Plant• As a lead in group, collaborate with various vendors for equipment orders to setup support operations media and buffer labs, weighing and dispensing lab and autoclave and washer areas.• Authored SOP, Batch Records, Protocol, validation document to start process in newly built cGMP Pilot Plant• Executed validation process for cGMP equipment (Autoclave, Washer, down flow weigh booth and Single Use Mixer) in support operations area. • Aided the transfer of new technologies/processes, operation and troubleshooting of equipment, preparation and close-out of documentation and ensuring compliance to relevant regulations. • Leading a team, trained newly hired employees and contractors in various support operations processes.• Cooperated with the vendor to develop design for various media/buffer and single use mixer bag and custom tube sets for the single use mixing technology to manufacture media and buffer.• Perform weighing and dispensing, raw material sampling and prepared media/buffer solution utilizing disposable mixing technology to support upstream and downstream and tech transfer processes.

Spring House, Pa

• Provided valuable input and assisted in the development of design, implementation and validation of new technology such as disposable 750L Single Use Mixers.• Skilled with disposable mixing technology using Single Use Mixers (750L Single Use Mixer manufactured by HyNetics). • Knowledgeable in using SAP version 4.7 (R3 ECC) , GUI version 7.1 • Lead and coordinated activities for the preparation, use, assemble, disassemble, SIP and CIP of 2000L, 1000L and 500L of media and buffer formulation tanks and other equipment. • Authored, revised, review and approved Batch Records, SOP's, investigation reports, change controls and deviations. • Introduced new laboratory instruments into cGMP areas, create change controls and implementation plans related to instruments.• Aided in technology transfer to other departments and sites. (Development through Phase III).• Excellent trainer, able to make complicated tasks simple.• Generate Processing Schedule to plan preparation of materials and operations of cGMP and non-GMP materials to support processing schedule.• Monitoring and sampling of bioreactors using CEDEX, NOVA, and BGA.

Spring House, Pa

• Environmental Monitoring of Manufacturing suites using RCS Plus Air Sampler, SMA Air Sampler, Met-One Particulate counter, Water, Clean Steam, Compressed Air.• Performed bioburden testing by membrane filtration and pour plate technique for various water samples and other intermediate process samples.• Assisted with the validation and implementation of equipment.

Bensalem, Pa

• Maintained eligibility records related to patient health plan. • Corrected wrong or unreadable prescriptions.• Maintained patients profile and insurance claim forms.

Gujarat, India

• Managed group of FTE’s working primarily in production of vaccine and equipment preparation processes.• Equipment cleaning validation and qualification of cleaning for R&D projects and routine production.• Initiated, investigated, conducted root cause analysis of quality issues and ensured prompt closure of various nonconformance reports for shift. • Reviewed manufacturing procedures and equipment use records prior to submission at the end of each shift. • Developed and revised SOP’s and Batch Records for manufacturing use.

Master’S Degree, Microbiology

Bachelor’S Degree, Microbiology