Rahul Srinivas, MS, PMP

Experience

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  Wyeth

  Jun 2006 - Aug 2006

  Intern III

  • Worked on Lyophilization process improvement • Developed a visual basic integrated methodology for systems improvement

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  Hospira, Rocky Mount

  Jul 2007 - Apr 2008

  Validation Engineering Technician

  • Ensured validation activities were completed per cGMP practices and facility specifications• Responsible for sample testing with the CQA Lab to ensure that processes met quality specifications • Led Mixing and Fill Uniformity Validation projects to ensure that product remained homogeneous • Led Cleaning Validation projects which removed product residues from equipment to acceptable levels• Ensured validation activities were completed for introduction of new products to manufacturing facility• Documented site’s ability to manufacture product that met all process and final release quality attributes• Coordinated production personnel to follow current cGMP practices • Responsible for supplemental validation activities due to change in existing product or commodity Show less

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  Veterinary Medicine Library

  Aug 2008 - Dec 2009

  Student Assistant

  • Responsible for managing the circulation desk • Assisted patrons with queries including equipment problems• Learned to properly follow up with the supervisor and improved my communication skills• Developed the ability to prioritize my tasks and better manage time

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  Trex Company

  Aug 2010 - Jul 2012

  Formulations Development Engineer

  Key role and responsibilities:- Development and evaluation of prospective formulation for new products and improvement of existing products, including development of Color Concentrates- Provide support for new product development from formulation to product launch- Oversee Quality Assurance testing of raw materials- Document and maintain test methods and test results through a Quality Test Database Management system

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  ADVENT Engineering Services, Inc.

  Jul 2012 - Feb 2022

  Client - Genentech, SSFCurrently providing a combination of Global Project Management and Change Control expertise on Global Projects. Client - Genentech, SSF- Site manager at client site- Project procurement- Project management and budget tracking- On-boarding and training ADVENT engineers at client location- Perform process engineering activities Client - Fujifilm Diosynth Biotechnologies Inc., Morrisville, NC● Write proposals and summary reports for equipment requalification● Perform validation activities per site master plan● Equipment requalification include autoclaves, freezers and refrigerators● Update P&ID and hardware specifications for WPU (Water Purification Units) and WFI (Water for Injection) systems

  • Project Manager

    Mar 2018 - Feb 2022

  • Sr. Project Engineer

    Sept 2017 - Feb 2022

  • Project Engineer

    Jan 2014 - Sept 2017

  • Process Engineer

    Jul 2012 - Dec 2013
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  BioMarin Pharmaceutical Inc.

  May 2017 - Dec 2017

  Consultant

  Project manager for the Operational Readiness of the new Gene Therapy facility.

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  Centofanti Consulting, Inc.

  Apr 2022 - Feb 2023

  Project Manager

  Client - Kite PharmaProgram Management Consultant – set up the program infrastructure for Quality Control (QC) & Analytical Development (AD) 5-year Strategic Roadmap Program, including:- Develop a strategic roadmap to reach end state- Identify critical path items and key decision points to allow efficient program-associated projects sequencing- Identify key risks and a process to manage them- Develop an overarching implementation and resource plan for the whole program.- Provide ongoing program management support to QC and AD including strategic alignment on QC/AD coordinated efforts. Show less

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  Just - Evotec Biologics

  Dec 2023 - now

  Senior CQV Engineer