Bhanu Rohith

About Bhanu Rohith

As a highly skilled and experienced Manufacturing Process Equipment Engineer, I am confident that I can make valuable contributions to any organization in need of my expertise. With over 6 years of experience in engineering, validation, and operations, and a deep understanding of cGMP and GEP requirements, I am well-equipped to manage and execute various projects related to facility and utility management, EHS, and validations for pharmaceutical manufacturing process equipment.Professional Summary :• Managed Engineering and Operations projects, Validations, Facility and Utility Management, and EHS Projects.• Led and managed a team of engineers and technicians to execute multiple projects.• Deep understanding of cGMP and GEP requirements for all pharmaceutical manufacturing process equipment, including Coating machines and Roller compactors.• Worked extensively with design engineers to examine the accuracy of HVAC system designs in compliance with FDA 21 CFR part 11.• Generated and executed IQ/OQ/PQ of multiple new Trane HVAC Units covering complete manufacturing of one formulation unit as well as Area qualification and HEPA integrity tests to meet required ACPH and Differential pressures.• Prepared and executed numerous validation documents for manufacturing equipment like Tablet presses, roller compactor, fluid beds, granulators, and capsule machines.• Ensured timely requalification of various process machines regarding changes/modifications as required by Change controls.• Involved in cleaning validation of Process machines by providing product contact surface area for Cleaning validation protocols.• Possess good knowledge of Piping and Instrumentation diagrams (P & ID), PLC, and troubleshooting of various process machines like Compression, Encapsulation, and Granulation for minor issues.• Skilled in managing Preventive and Breakdown maintenance of facility equipment like HVAC, Boiler, Chiller, Air Compressor, and manufacturing equipment by maintaining essential spare parts to reduce downtimes during breakdown.• Committed to introducing new and updating existing SOPs related to equipment and instruments to improve the work environment from a safety and quality point of view.I am excited to bring my skills and knowledge to contribute to the success of any organization I work along.

Experience

1. Engineering Manager

   Novo Nordisk

   Oct 2024 — Present · Durham, NC, US

Education

• Louisiana Tech University

  Master's Degree, Industrial Engineering

  2014 — 2016

• BVRIT

  Bachelor's Degree, Chemical Engineering

  2010 — 2014

• Louisiana Tech University

  Master of Science - MS, Industrial Engineering

Skills

• Microsoft Powerpoint
• C
• Research
• Data Analysis
• Java
• Powerpoint
• Microsoft Excel
• Photoshop
• Microsoft Office
• Solidworks
• Teamwork
• Six Sigma
• C++
• Lean Six Sigma
• Microsoft Word
• Matlab
• Chemical Engineering