Niraj Pradhan Email & Phone Number

Indianapolis, Indiana, US

South Bend, Indiana, US

South Bend, Indiana, US

Warsaw, Indiana, US

• Deliver the Quality Excellence QMS improvements in support of the corporate strategic plan
• Perform raw data analysis, data verification, gap analysis and provided support on the current quality system metrics
• Conduct monthly and quarterly quality system management review meeting and follow up on the action items
• Monitor and manage CAPA, Non-conformance and Product Hold status through daily reporting and burndown charts
• Support Process Monitoring and validation project related to various quality processes such as diffusion bonding
• Support calibration of various Gages and support any issues due to Gage rejection

Lawrence Township, NJ, US

• Performed data analysis and process robustness analysis based on QbD methodologies for all drug product manufacturing sites
• Implemented design control strategy to develop an end to end process performance
• Supported global investigation of process deviation, data trending and change controls
• Supported green belt project execution using Lean 6-Sigma methodologies
• Performed batch analysis of commercial, engineering and clinical batches to develop Cpk models providing key process parameters and CPPs for process monitoring
• Performed manual and automatic process performance data extraction, reporting and analysis

Binghamton, NY, US

• Investigated the differentiation of hPSC into beta cells for the treatment of Type II diabetes
• Researched on biodiesel production (upstream and downstream process) using microalgae
• Designed paper-based microfluidics device for the separation of the blood-plasma proteins
• Investigated drug target prediction using the complex data network theory

Somerset, NJ, US

• Performed GMP Master Batch Record (MBR) development, review and approval process for clinical and pre-commercial development drug products
• Provided direction, input, review and approval of Engineering studies, validation protocols and reports for facilities, equipment, systems and utilities to ensure thoroughness, accuracy and compliance with company.
• Wrote SOP for manufacturing equipment like Blenders, Roller Compactors, Fitzmills, Oscillating Granulator, Encapsulators and revised existing procedures as needed
• Supported in design and implementation of new manufacturing processes or changes to existing processes and oversee new equipment implementation and validation
• Reviewed formulation process protocol including DOE and formulation development report for solid dosage form manufacture.
• Wrote deviations/non-conformances and investigation reports for any manufacturing process issues

Paris, France, FR

• Performed validation of analytical instruments like HPLC, GC, LCMS, UPLC, Atomic Absorption Spectrometer, UV/Vis Spectrophotometer, Karl Fisher Titrator, cIEF, Laser Densitometer, Face Imager, Particle counter, TOC.
• Authored User Requirement Specification (URS), Configuration Specification (CS), IOQ and PQ for the Analytical Instruments
• Executed SAT, IQ, OQ and PQ, analyzed validation protocol execution data and prepared validation summary report
• Involved in performing GAP Analysis to investigate gaps between system operation and the requirements of FDA regulations over the current system and prepared Remediation Plan to fix the gaps identified
• Initiated and approved CAPA and change control for any deviation encountered during the validation process
• Performed a peer review meeting process with the Quality Control and Quality Assurance management team to review and approve the validation documents

New Brunswick, NJ, US

• Responsible for writing and executing Validation Protocols (SAT, IOQ & PQ) and Commissioning Test Protocols for utility systems(Clean Steam Generator, Pure Water Generation and Distribution, Compressed Air Unit, Plant.
• Worked in compliance with FDA regulations and cGxP guidelines in all the aspects of Validation process
• Conducted Vendor documentation verification, design specifications and updated Engineering Drawing and P&IDs of all the utilities and equipment based on change requirements
• Validated Allen Bradley PLC/HMI system based process equipment and testing of SCADA system
• Developed and reviewed Standard Operating Procedures (SOP’s) for Preventative Maintenance of utilities and process instruments
• Performed temperature-mapping validation on different types of instruments using KAYE Validator 2000

• Support Generation of User Requirement Specifications and execute engineering documents pertinent to commissioning
• Perform field/site activities pertinent to FATs and SATs, vendor start-up testing, and execution of commissioning, qualification and validation protocols.
• Author validation documentation including, but not limited to, Installation, Operational and Performance Qualification protocols and reports, Process Validation protocols and reports, Cleaning Validation protocols and.
• Prepare Cleaning and Process validation protocols according to internal and external requirements.
• Execute qualification, cleaning and process validation tests in accordance with approved protocols, procedures and guidelines.
• Analyze cleaning and process validation test data to determine systems have met validation criteria.

Edmond, OK, US

• Designed and assembled micro tension and bend test setup for in-situ and ex-situ Field Emission Scanning Electron Microscope (FESEM) conditions
• Designed experiment to conduct fracture strength of bone-composite cement
• Examined the effect of Hydroxypatite and Chitosan nanoparticles on the fractural strength of PMMA bone cement
• Investigated the influence of biomaterials on the interfacial fractural strength of PMMA bone cement
• Designed Whiplash mechanism using automated tensile testing machine
• Designed temperature controlled bath for the analysis of engineered tissue grafts

Drug And Medical Device Development

Project Management

Master Of Science (M.S.), Bioengineering And Biomedical Engineering

Bachelor Of Science (B.S.), Biomedical/Medical Engineering Minor: Mathematics