Addepalli Sri Ranganadh

Roles & Responsibilities:

Head of Projects - Automation & Instrumentation, a corporate role to create and rebuild facilities with the latest digitalization technologies – working on 3 projects from conceptual design to Execution

• Project management of R&D facility – Hyderabad

o EMS system – Schneider Eco structure - GMP system

o iBMS - HVAC, Power and utility Management, Door Access Systems,

Fire Alarm System integration - Non-GMP system

• Project Management of API facility – Jaipur, India -

o SCADA system - GMP system

• Establish the scope, objectives, and deliverables of the project or program in alignment with business goals, collaborating closely with senior management and stakeholders.
• Guide the project team in executing the project plan, overseeing progress, and implementing necessary adjustments.
• Oversee the project budget effectively - Implement cost-saving strategies through careful planning and enhanced efficiency.
• Identify potential risks and formulate strategies for mitigation.
• Ensure that project deliverables adhere to quality standards, fulfill business requirements, and achieve desired outcomes.
• Maintain thorough project documentation, change management, including plans, reports, and evaluations after project completion.
• Coordinate resources across various projects, managing interdependencies and resolving any conflicts that arise.
• Execute GxP projects to comply with life sciences regulatory standards while fulfilling customer expectations. Additionally, oversee and evaluate the necessary qualification processes, including validation plans, risk assessments, requirements traceability matrices (RTM), and the various qualification stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Worked as Project manager and deputed to Europe site for the Project

• Project Management of PP facility – Lodi, Italy
• DCS & MES System – Siemens PCS 7 & Opcenter
• GxP Qualification
  

Roles & Responsibilities:

Group Lead for Projects & Engineering, overseeing multiple automation and instrumentation initiatives at API, PP, and OSD facilities.

Key Achievements -

1. Successfully implemented the Rockwell DCS & FT Batch automation project at the PP facility, achieving qualification in compliance with local regulations, US FDA standards, GAMP, and 21 CFR part 11.

2. Deployed a centralized Building Management System (BMS) using Siemens Desigo CC 5.0 (VM Server and Web client) for HVAC systems across three blocks (two API and one OSD facility) to uphold ISO class 8 standards.

3. Established a Manufacturing Execution System (MES) utilizing Rockwell Pharma Suite - FTPS for the dispensing processes in API and formulation blocks.

4. Integrated utility and purified water systems with a historian, connecting all systems and the PI historian to create an electronic logbook, ensuring data integrity (ALOCA+) through this digitalization effort for API and OSD facilities.

5. Developed an IoT-based smart water quality monitoring system for real-time tracking, AWS cloud storage, and alert generation, along with data analytics to forecast potential failures.

• Quality Management System - Managed equipment validations, risk assessments, and 21 CFR part 11 evaluations, documenting in accordance with GAMP and cGMP guidelines for new projects.
• Oversaw change management for continuous improvement and brownfield projects. Worked closely with IT to establish control system backups and address automation needs, including the deployment of Data Historian and Active Directory.
• Supervised lab equipment installation and commissioning, ensuring compliance with 21 CFR part 11 requirements. Provided guidance to the team to uphold GxP processes for Computer System Validation (CSV).

Roles & Responsibilities:

Served as the project manager for Automation & Instrumentation on a greenfield project.

Key Achievements:

1. Successfully deployed and implemented Simatic Logon for process equipment.

2. Executed the deployment of KepserveEx & BDI to enhance MES AMS IP21 support.

3. Integrated OSD equipment automation, developed functionality, reviewed the SDLC, and conducted qualification (DQ, IQ, and OQ).

4. Deployed a CMMS application to facilitate calibration and maintenance functions.

• Collaborated with cross-functional teams to identify areas for process improvement.
• Managed a team of automation engineers to ensure timely completion of projects and optimal system performance.

Roles & Responsibilities:

• Served as the Project Coordinator for facility enhancement initiatives and the new greenfield project of the OSD facility.

Key Achievements:

• 1. Formulated an automation strategy and roadmap to prepare the organization for Industry 4.0.
• 2. Enhanced existing equipment control systems, ensuring compliance with GxP standards.
• 3. Selected and integrated new equipment with upstream and downstream systems to reduce manual interventions.
• 4. Transitioned from manual records to electronic records and e-logbooks.
• 5. Implemented SCADA and PLC projects for the coating and granulation processes.
• 6. Developed budget estimates and collaborated with SCM and finance teams to manage costs for new equipment and vendor management for the greenfield project.

Roles & Responsibilities:

• Worked as Engineer in Automation & Instrumentation team for continuous improvement projects implementation.
• Key Achievements:
• 1. Successfully deployed several complex and innovative projects to improve yield, reduce market complaints, meet new market are regulations - such as US FDA, MHRA, TGA, etc.
• 2. Automated the solvent dispensing system, water system and DG power, etc.