Darpan Bhaiya
Validation Engineer at Novo Nordisk | MS in Pharmaceutical Manufacturing Engineering
- Role
- Validation Engineer at Novo Nordisk
- Location
- Bloomington, IN, US
- LinkedIn followers
- 500 followers
Experience
Validation Engineer
Dec 2024 — Present · Bloomington, IN, US
Led validation protocols including installation/operational qualifications and requalification on process equipment and utilities Revised validation documents including protocols and SOPs with guidance from Engineers and Supervisor Accessed and compiled data and generate qualification reports from control systems; complete and review calculations and perform technical review of validation documents Assisted with investigations, change controls, and similar activities Drafted new protocols for systems similar to existing site systems Participated in generating system lifecycle documentation, including requirement specifications, risk assessments, criticality assessments, and trace matrices Presented qualifications to clients, auditors, and inspectors Coordinated with other internal groups including QC, engineering, automation, and production to complete execution of validation protocols and other tasks Demonstrated familiarity with industry guidance documents for equipment validation Executed validation tasks and projects to achieve project timelines Reviewed work orders and similar records for validation impact
Education
Adarsh Junior College, Akola
12th Grade, Science
Vidyalankar Institute of Technology, Mumbai
Bachelor of Engineering - BE, Electronics Engineering
Emerald Heights School, Akola
10th Grade
Stevens Institute of Technology
Master's degree, Pharmaceutical Manufacturing Engineering
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