Pavan Kumar P

About Pavan Kumar P

I am a top performing Automation, Instrumentation & CSV Professional with 20+ years of experience in leading the areas of Detail Engineering, Project management related to process Instrumentation, Calibration and automation for Pharma/Life Science industries including regulatory requirements for Automation & IT Solutions. Possessing clear understanding of the industry’s technology trends with insightful Life Science Industry’s experience’ for full life cycle implementation for process automation such as Feed engineering, Requirements gathering, Conguration, Design, Development Testing, Installation, Commissioning including qualication & regulatory compliance. Presently associated with Sano Healthcare India Pvt. Ltd, Hyderabad as Sr. Manager (Project Process Tech Transfer Lead – Instrumentation, Automation & CSV). As an enterprising personality and a multifaceted individual, I have demonstrated strength by successfully achieving approvals from regulatory auditors like WHO, FDA & MHRA during my work experience. I also got recognized for eciently managing Instrumentation team of technicians in maintaining of plant instruments maintenance, Calibration and control systems. Highly appreciated for planning and completing the new production block which runs on Siemens Simatic Batch Control Centre (BCC) with intrinsically safe RIOs located in the eld. Project received PSAI Award for rst fully automated Plant in Dr Reddy\'s. Another feather in my cap is my excellent knowledge of cGMP/CSV qualication & Validation and regulatory requirements such as 21 CFR Part 11 (cGMP, GMP, GAMP V, ICH). Well-versed with S88/S95 standards. Passion, focus, intensity, steadfastness, curiosity, impatience (when necessary) and being ercely loyal are all characteristic that have enabled me to achieve success inside and outside the oce. If you would like to know more about my experience, please contact me on +91••••••••77 and email at: v••••••••@yahoo.com

Experience

1. Sr Manager (Project Process Tech Transfer Lead Instrumentation, Automation & Csv)

   Sanofi

   Feb 2018 — Present

   In my current capacity, I am responsible for instrumentation, Calibration, automation and CSV Lead in insulin manufacturing plant with a team of 6. I am also accountable for implementation of Quality Operations including calibration management in insulin manufacturing plant. Eciently handling implementation of site computerized system validation as per regulatory requirements. Actively working as a Project Process tech transfer lead for insulin manufacturing plant. Instrumental in identifying & managing company initiatives for integrated process automation related used upstream & Downstream bioprocess Operations’ (Vaccines). Prociently handling deployment of standardization, unied architecture, and participate in partner selection, technical evaluation & their audits. Auditing project sites to ensure 100% compliance w.r.t regulatory requirements & company quality policy. Skillfully preparing Budgets, Resource Planning & Execution obtaining their approvals. Following Safety & ensure Zero accident during the execution. Eectively coordinating with cross functional teams including IT. Ensuring 100% on time project delivery, with min Inventory & reduced man hour through optimized Automation solutions, consolidation of applications. Supporting manufacturing for external regulatory audits. successfully executed various projects, 1. Standardization of Instrument Calibration procedures across the site. Implemented CSV of Process and laboratory systems in site from scratch i.e, validation strategy nalization cum implementation. Deployment of PCS7 with PH for Integration of various bioprocess equipment\'s along with its installation, commissioning & qualications 4. Deployment of UMS for monitoring of utilities consumption. Installation, commissioning and qualification of formulation system on Siemens PCS7 with Simatic Batch on virtualization server 6. Designing, Installation, Commissioning and qualication of Local Data Historian at insulin site.

Education

• Kakatiya University

  Master's degree, Instrumentation

  1998 — 2000