Piyush Ranjan

►Lead Engineering representative SME managing facility and manufacturing capital manufacturing drug substance,
reviewing leaching studies , process control strategy of fill finish & managing site expansion projects globally
► Mentoring & guiding junior process engineers & contractors to support manufacturing and lab processes
► Working with cross functional teams to prepare responses with EMA and FDA for parenteral drug product fillings
► Initiating, Reviewing & providing Engineering impact assessment to approving Change controls, IOQ, URS, FAT &
SOP, commissioning, TOP package documents of Equipments for vaccine manufacturing process
► Providing active equipment support to all Global sites & CMO sites in India & Europe for drug
substance & fill finish operations, engineering evaluations of labs & manufacturing Equipments of drug product
► Reviewing & developing PFDs, PIDs and equipment specifications of process and process utility Equipments for
drug substance and filling drug products, helping in designing the equipment process design
► Developed PFDs of analytical, process development, clinical immunology, and QC labs and its commissioning
► Creating a strategy for procuring & standardization of Equipments for the PD, Upstream & downstream process
► Collaborating with CMOs to help them with equipment selection & troubleshooting of drug substance & products
► Developing strategy for equipment procurement & commissioning for COVID & pipeline expansion projects
► Supporting the MS&T Tech Transfer & QA validation for process validation, providing impact assessment for
change controls, CAPAs and deviations for drug substance operations

►Provided expert troubleshooting support during critical plant issues, quickly resolving incidents while minimizing production losses.

► Validating the analytical Equipments like TOC analyzers, Pall Filter Integrity filter Testers, LabChip
Electrophoresis system, Osmometers, Protein Simple (Ice3 CE), qPCR System, Nova Biomedical BioProfile Flex II Systems, Lonza Endotoxin Detection systems for supporting the QC microbiology, QC stability, QC Immunoassay, BPT Analytical, QC Bioassay and QC Chemistry
► Writing Installation and Qualification Configuration (IQC) tests, Functional Requirement Specification (FRS), creating deviation reports, repeat tests, executing the Installation and Operational Qualification (IOQ) executions
► Reviewing the implementation of Environment, Health, and Safety (EHS), Engineering risk assessment, audit trail assessments, Standard operating procedures, and Maintenance plan of analytical instruments.
► Writing final reports and troubleshooting Analytical Laboratory Equipments used for QC testing.
► Perform and support investigations arid address CAPA (Corrective and Preventive Actions), Deviations, change controls and that arise during the IQC & IOQ validation of labs & manufacturing equipments

►Authoring & reviewing validation protocols of equipment's like autoclaves, freezers, bioreactors, tanks, pumps, HPLC, sterile filter validation & chemistry of drugs in pharmaceutical facility according to FDA & EMA regulations
► Reviewing Cleaning Validation (IQ/OQ, CIP & SIP), E&L, E&L stability studies, toxicological assessments, etc.
► Reviewing equipment validation protocols, standard operating procedures for compliance for product safety

• Using engineering skills to run a continuous biodiesel downstream production process to provide quality products that meets the B100 biodiesel quality; operating distributed automated control system operations

• Developing filter characterization methods via analytical methods for investigating surface morphology of thin film composite membranes

• Successfully build reverse osmosis set up for measuring downstream purification membrane transport properties

• Executing Temperature mapping of chambers and autoclaves using data loggers and Kaye validators and reviewing cleaning validation data analysis and reporting

• Process and equipment design of heat exchangers storage tank pressure vessels, centrifuge, process skids, etc.

Product designing aspect of the utility equipment used such as heat exchangers & Evaporators, Cost estimation and analysis of the engineering projects, equipment, and processes for production of diethyl phthalate,

working with FSSAI quality regulations

• Successfully helped save the company around 50 million dollars for the maintenance by preparing investigating report on corrosion in process equipment of oil refinery, process unit operations & waste solutions