Gianluca Borrelli
About Gianluca Borrelli
Gianluca Borrelli is the CSV Lead Engineer at Bristol Myers Squibb in Summit, New Jersey, with extensive experience in mechanical engineering and software validation in the pharmaceutical industry.
Title
Gianluca Borrelli holds the position of CSV Lead Engineer at Bristol Myers Squibb in Summit, New Jersey, United States.
Company
Gianluca Borrelli currently works at Bristol Myers Squibb, a global biopharmaceutical company. As a CSV Lead Engineer, he is responsible for leading the implementation of Manufacturing Equipment and Laboratory software systems in GMP Pharmaceutical environments.
Professional Experience
Gianluca Borrelli has accumulated substantial professional experience through various roles. He started as a Technical Service Intern at Chemetall North America in 2013, followed by a Product Development Intern at Zimmer Biomet in 2014. He has interned at Mentor Worldwide LLC and served as a Teaching Assistant at Stevens Institute of Technology. His extensive experience includes positions such as Electro-Mechanical Integrator and Consultant at Excellis Health Solutions, Serialization Engineer/Business Analyst at Renaissance Lakewood, LLC, and CSV Engineer at Bristol Myers Squibb, culminating in his current role as CSV Lead Engineer.
Education and Expertise
Gianluca Borrelli completed both his Bachelor of Engineering (B.E.) and Master of Engineering (M.Eng.) in Mechanical Engineering at Stevens Institute of Technology. His education has equipped him with expert knowledge in CAD and GD&T, and he is proficient in AutoCAD, Solidworks, NX8, and Pro/E (CREO). Throughout his academic and professional journey, he has developed design control documentation and managed vendor relations to implement serialization systems.
Role Responsibilities
In his role at Bristol Myers Squibb, Gianluca Borrelli develops design control documentation, including Validation Plans, URS, FS, FATs, SATs, IQ/OQ/PQs, Trace Matrices, and SOPs. He manages software vendors to design software that meets corporate and regulatory requirements and develops Quality Documentation of system configuration and usage for compliance with 21CFR11 and 21CFR820.