Dhruv Jain  Ms. MBA

Dhruv Jain Ms. MBA

Sr Validation Engineer @ BeiGene

About Dhruv Jain Ms. MBA

Dhruv Jain is a Sr Validation Engineer at BeiGene in New Jersey, specializing in cGMP manufacturing operations for the Bio-Pharma industry with extensive experience in commissioning, qualification, and validation.

Company

Dhruv Jain is currently employed at BeiGene as a Senior Validation Engineer. Situated in New Jersey, United States, this role is conducted on-site. BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to treat cancer.

Title

Dhruv Jain holds the position of Senior Validation Engineer at BeiGene. This role leverages his extensive background in supporting cGMP manufacturing operations specifically within the Biotech, Cell and Gene Therapy, medical devices, and the Bio-Pharma industry.

Education and Expertise

Dhruv Jain has acquired significant educational qualifications that bolster his professional expertise. He earned an Executive MBA specializing in Project Management from the University of the Cumberlands in 2021. Additionally, Jain holds a Master’s Degree in Chemical Engineering from the New Jersey Institute of Technology, completed in 2016. These academic credentials support his expertise in commissioning, qualification, and validation (CQV), and his knowledge of regulatory compliance across multiple frameworks including cGMPs, GEPs, GDPs, GAMP, CFR21 Part 11, and ICH guidelines.

Professional Background

Dhruv Jain has amassed a comprehensive professional background with a series of roles in various organizations. Starting as a Research Assistant and Chemical Engineer Tutor at New Jersey Institute of Technology, he later transitioned to the industry, working at companies including Adello Biologics, LLC, Zimmer Biomet, Alcon, and Lonza. His roles varied from Quality Engineer to Validation Engineer, up to MSAT Senior Scientist. Notably, he served at Sanofi as a Senior Validation Engineer for 9 months in 2023-2024, and now continues at BeiGene in the same capacity. His work history underscores his capabilities in troubleshooting, problem-solving, project planning, coordination, and execution.

Industry Compliance and Skills

Dhruv Jain's role as a Senior Validation Engineer requires adherence to stringent industry compliance standards. He ensures compliance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEPs), Good Documentation Practices (GDPs), Good Automated Manufacturing Practice (GAMP), CFR21 Part 11, as well as International Council for Harmonisation (ICH) guidelines. His expertise extends to effectively handling multiple tasks in dynamic environments and he is recognized for his effective communication skills that positively impact team environments.

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