Sushil M.

About Sushil M.

With background in Chemical Engineering (B.S) from the University of Oklahoma, I have developed a passion for the biotech and life sciences industry. Currently, as a Process Excellence Engineer at Boston Bioproducts, I look forward to contributing and learning to further develop my skills as a professional in this space. While assisting in process excellence initiatives, we\'ve implemented automation systems that optimizes manufacturing processes and serve as a support to the Manufacturing, Quality Control, Quality Assurance and Process Development Teams. As part of the team, we conduct comprehensive equipment qualifications and calibrations, facilitate validation projects, and lead training programs for production technicians. Our focus is on optimizing production flows and maintaining strict quality control.

Experience

1. Process Excellence Engineer

   Boston BioProducts

   Jan 2024 — Present

   Led and executed validation projects, including the performance and documentation of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) when applicable.Responsible for the onboarding of new equipment and procedures, ensuring smooth integration into lab workflows.Led the successful implementation of a new Equipment Management Software, improving asset visibility and streamlining maintenance scheduling.Coordinated and performed preventive maintenance and calibrations for all laboratory equipment, ensuring reliability and compliance.Managed the design and development of product packaging (e.g, bioprocess containers, bottles, and tubes) based on customer specifications, in collaboration with cross-functional stakeholders.Worked cross-functionally with Quality, Production, Commercial, and Sales teams to align operations with business and regulatory requirements.Trained laboratory personnel on proper usage and best practices for new equipment, enhancing efficiency and reducing operational errors.Supported and scoped new equipment needs for newly onboarded processes, aligning capital planning with production goals.Led and executed validation projects, including the performance and documentation of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) when applicable.Monitored and responded to Building Management System (BMS) alerts for temperature, humidity, and differential pressure, maintaining environmental control and proper documentation.Authored and revised Standard Operating Procedures (SOPs) and Work Instructions for new equipment and process improvements.Ensured all lab equipment was compliant with Equipment Management SOPsSupported the execution of client-specific specialty projects, ensuring all outcomes aligned with customer expectations, technical specifications, and quality standards

Education

• University of Oklahoma

  Bachelor of Science - BS, Chemical Engineering

  2015 — 2019