Abhimanya K.

Abhimanya K. has a diverse work experience in the field of validation engineering. Currently, they hold the position of Senior Validation Engineer at Organogenesis since July 2022. In this role, they are responsible for preparing protocols and reports for validation and revalidation work, coordinating and executing validation studies for various equipment, performing testing using standard cGMP processes, and reviewing equipment history files.

Prior to this, Abhimanya worked as a Validation Engineer at MMR Consulting from February 2021 to July 2022. Here, they performed performance qualification of different grade rooms, conducted cleaning verification for sterile filtration skids and filter presses, and executed mixing studies for compounding tanks.

Before joining MMR Consulting, Abhimanya worked at Sanofi as a Principal Commissioning and Validation Engineer II from April 2019 to January 2021. In this role, they were responsible for validation activities in a GMP biotech manufacturing facility, qualified new equipment such as autoclaves and incubator shakers, managed small-scale validation projects, and performed change control-based qualification/validation activities.

Abhimanya also has experience as a Validation Engineer at Raritan Pharmaceuticals Inc. from August 2018 to March 2019. Here, they were involved in quality and validation activities, commissioning and qualification of a new manufacturing facility and equipment, and performing root cause analysis as part of corrective and preventive actions.

Furthermore, Abhimanya worked as a Project Analyst at The Ogni Group from August 2017 to July 2018. In this role, they conducted energy audits, interacted with clients to discuss project goals and progress, and promoted and trained Lean/Six Sigma values and tools.

Abhimanya's earliest work experience was as an Intern (Procurement & Process Development) at Spicer India Ltd from June 2013 to December 2013. In this role, they planned and organized production schedules, assessed resource requirements, and oversaw production processes while determining quality control standards.

Abhimanya K. completed a Master's degree in Engineering/Industrial Management from Texas A&M University-Kingsville from 2015 to 2017. Prior to that, from 2011 to 2015, they obtained a Bachelor's degree in Automobile Engineering from SRM University. In addition to their academic achievements, Abhimanya has also obtained the Lean Six Sigma Green Belt Certification from the Six Sigma Global Institute in February 2018. They have also completed a course on Project Management with Primavera P6 from Udemy, although the specific timeframe for this certification is not provided.