Shine Kumar

About Shine Kumar

Anassiduous, aspiring & dynamic Senior Management Professional, offering 21+ years of versed & augmented experience in Instrumentation /Automation Engineering, Commissioning/Qualification/Validation, Computer System Validation, Mechanical Maintenance, Process/Packaging Engineering, Project Management, Quality Management System, Capex/Opex Management, Quality Management, Regulatory Compliance, Supplier Management, and People Management. WHERE CAN I ADD VALUE I am a seasoned pharmaceutical industry expert with a laser focus on engineering operations for both oral dosage form and sterile Fill & Finish processes. Throughout my career, I\'ve been at the forefront of driving excellence in pharmaceutical processes, maintenance, instrumentation/automation, computerized system validation, and engineering projects & quality management systems, Commissioning/Qualification/Validation. My contributions extend to key roles in engineering activities related to production and packing machines, instrumentation/automation, quality management systems, engineering projects, and mechanical and electrical upgrades. I bring proficiency in handling a wide array of systems and instruments, including PLC, HMI, DCS, SCADA, control systems, datalogging systems, calibration, UPS, VFDs, and IoT platforms such as Track & Trace and Vision Inspection systems. In the realm of pharmaceutical engineering, I bring a strong background in cGxP & GAMP validations, including Computerized System Validation (CSV), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), among others. My proficiency extends to various pharmaceutical machinery, SAP-controlled systems, Building Management Systems (BMS) and Building Automation Systems (BAS), oral dosage process and packing machines, sterile fill and finish machines, Inspection systems, HVAC, lyophilizers, and GMP washers. A significant part of my expertise lies in quality management systems, where I\'ve successfully managed change controls, CAPAs, deviations, investigations, audit responses, and ensured unwavering regulatory compliance. Additionally, I\'ve served as a subject matter expert in regulatory audits, including those conducted by USFDA, MHRA, TGA, and Health Canada, where I\'ve played a pivotal role in ensuring compliance through effective Corrective, Preventive and troubleshooting Actions (CAPAs) using SAP PM module. Do reach me out at:s••••••••@gmail.com

Experience

1. Manager Instrumentation Engineering

   Biocon Biologics

   Jul 2021 — Present · Bengaluru, IN

   People Leader, who has successfully led and motivated teams in cross cultural environment towards growth and success in the organization. KEY HIGHLIGHTS Specializing in comprehensive sterile process and machinery engineering activities. My expertise spans instrumentation/ automation/control systems, mechanical and electrical aspects, CSV, Project Management, and QMS. I bring a proactive approach to machine maintenance, swiftly executing corrective actions during…

Education

• Vinayaka Mission's Research Foundation - University

  B.tech, electronics and communication engg

  2006 — 2009

• Govt. polytechnic kushalnagar

  Diploma, Electronics and communication Engineering

  1999 — 2002