Pratap Jung Basnet

About Pratap Jung Basnet

Throughout my career, I have successfully delivered numerous process engineering and validation projects for clients across industries, including manufacturing, pharmaceuticals, and automotive. My key strengths include designing, developing, analyzing, integration and testing automation systems, as well as troubleshooting and maintenance. Moreover, I have also worked as a process engineer for a Vaccine formulation facility project on mRNA COVID-19 vaccine working on process simulations and risk assessments along with providing the process documentation and operating instructions. I have a strong passion for continuous learning and staying up to date with the latest advancements in automation and processes technology. As an experienced engineer, I strive to bring innovative solutions to complex challenges and help my clients achieve their automation goals. I am highly motivated person who believes in teamwork and communication, creativity and innovation which would lead to productivity in order to achieve goals of an organization and employee. I am a firm believer of,\"The early bird catches the worm\", indicating being proactive in order to achieve success. I am currently seeking new opportunities in the automation industry where I can apply my skills and experience to deliver successful automation and process projects. If you\'re interested in learning more about my experience or discussing potential opportunities, please feel free to connect with me.

Experience

1. Process Validation Engineer

   Pfizer

   Nov 2023 — Present · Rocky Mount, NC, US

   Generated, reviewed and executed Protocols associated with Process Validation and cleaning validation, Batch Records, data sheets, and different GMP documentations related to validation and release of commercial drug product batches.• Supported technology transfer activities, writing and reviewing Master Batch Record (MRB), writing PPQ protocols, RCA, sampling plans etc. • Managing and monitoring Process Validation activities along with sampling during the commercial manufacturing of drug products which includes formulation, Solution Hold times and the filling of aseptic and terminally sterilized solid volume parenteral products.• Change Controls and CAPA implementation, and initiated validation-related deviations or investigations.• Collaborated with Manufacturing Quality (MQ), operations, process engineers and automation engineers for continuous process validation and analyzed validation data to identify trends, implement corrective actions along with maintaining process robustness. • Optimized validation strategies for aseptic and terminally sterilized drug products• Create and implement cleaning validation protocols that align with Pfizer’s Standard Operating Procedures (SOPs), regulatory standards, and industry best practices (MACO, PPM). • Strong Knowledge of different documentations like FMR, 60ALLCODE, 35D, Exhibit Protocol, Development Batch Report, SOLP, Batch record etc. • Performing risk assessments for identification of CPP for cleaning validation and different potential sources of contamination.

Education

• Cameron University

  Master's degree, Business Administration and Management, General