Neeyav Shah
Director of Plant Operations @Made Scientific
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WORK HISTORY
Director of Plant Operations @Made Scientific
Princeton, NJ, US
In my role as Director of Plant Operations at Made Scientific in Princeton, NJ, I led a team to streamline facility operations, resulting in improved efficiency and reduced costs.
EDUCATION
Don Bosco Vadodara
Under grad
Stevens Institute of Technology
Master's degree, Pharmaceutical manufacturing and engineering
Bapuji Degree College
Bachelor of Pharmacy (BPharm), Pharmaceutical Sciences
SKILLS
ABOUT NEEYAV SHAH
Sr. Manager Technical Operations, BioCentriqMAR 2024-PresentManaging project timelines, ensuring timely milestones, and troubleshooting equipment or process issues. Taking the lead in process development and addressing deviations related to equipment used during pilot runs. Reviewing batch records from pilot runs, identifying errors, and providing training to ensure they areeliminated during the engineering run. Implementing an alarm management system through proper alarm response SOP. Conducting Contamination Control Strategy FMEA for a multi-client facility. Overseeing the relocation project from one facility to another. Contributing to due diligence efforts for Validation/Qualification. Proactively managing GMP readiness programs for Facilities, Equipment Validation/Qualification, and Aseptic Qualification. Projects Completed: Continuous improvement of clean rooms, cleaning validation, EMPQ program, Quality Management Systems Validation and CMMS.Validation Manager, BioCentriqOCT 2022-MAR 2024Establishing validation programs to meet current US regulatory expectations. Established Validation Master Plans for all BioCentriq facilities. Managing validation projects by aligning, coordinating, and supervising the prioritization of activities against the business needs. Reviewing and approving validation deliverables. Working with cross-functional teams to develop risk-based validation approaches and resolve complex validation issues. Communicating validation requirements, timelines, and resource needs to seniormanagement. SME for validation during client audits. Part of GMP readiness team and management.ECQ PROJECT DELIVERY SUPERVISOR, BRISTOL MYERS SQUIBBAUGUST 2021-OCT 2022Management: Create schedules and timelines for projects. Manage external project teams and set up weekly meetings for project updates. Updating project spreadsheets and timelines, presenting updated status to management. Serve as an SME for temperature mapping.Training: Train new employees as per compliance.Expenses and Budget: Manage expenses and budgets. Develop budgets and allocate them to different projects. Manage the budget for purchasing new equipment/instruments for the team.VALIDATION/SR. VALIDATION ENGINEER, BRISTOL MYERS SQUIBBMARCH 2019-AUGUST 2021VALIDATION ENGINEER, HEMISPHREX BIOPHARMA INC,MAY 2018-MARCH 2019QUALITY AUDITOR, AMNEAL PHARMACEUTICALS,MAY 2016-MAY 2018
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