Summary
Overview
Work History
Education
Skills
STRENGTHS
KEY ACHIEVEMENTS
Certification
Timeline
Generic

Venkatesh Doddapaneni

MES PAS-X Application Owner and MBR Designer
Hyderabad

Summary

Accomplished bio pharmaceutical professional with over nine years of experience in production and more than four years specializing in MES engineering, focusing on upstream and downstream processing of monoclonal antibodies and small molecules. Demonstrated expertise in leading digital manufacturing initiatives that enhance system reliability, ensure regulatory compliance, and promote operational excellence within large-scale environments. Committed to leveraging innovative solutions to optimize processes and drive efficiency in the bio pharmaceutical sector. Recognized for a results-oriented approach that consistently meets and exceeds industry standards.

Overview

14
14
years of professional experience
3
3
Certifications
3
3
Languages

Work History

PAS|X Application Owner & Administrator

TheraNym Biologics Private Limited
02.2025 - Current
  • Concentrate on MES PAS X implementation alongside all integrations
  • Spearheading MES implementation for PAS.|X 3.3.5 at the manufacturing site, ensuring alignment with operational and regulatory standards.
  • Facilitating workshops with cross-functional stakeholders to define User Requirements Specifications (URS), and functional requirements.
  • Documenting end-to-end process flows and system interfaces to support seamless MES integration.
  • Working closely with Production, Quality Assurance, IT, Automation, and Engineering teams to translate business needs into MES functional specifications.
  • Provide technical inputs to the manufacturing and CFT teams on streamlining the process batch records.
  • Conducting comprehensive training sessions for end users to ensure effective adoption.
  • Discussing with the SAP and CFT teams on the finalization of the recipe and BOM for the business process.
  • LIMS, QMS, and Data Historian systems integration to MES, initiate process flow discussions and finalization.
  • Performed FIT-GAP analysis with Körber PAS.|X team and process owners, along with all the CFT.

PAS|X MBR Designer

Dr. Reddy's Laboratories
08.2023 - 01.2025
  • Focused on PAS.|X integration and MBR design.
  • Led MES implementation for PAS.|X (3.1.8) at the manufacturing site.
  • Designed manufacturing processes using PAS.|X in the bio pharmaceutical industry.
  • Designed Manufacturing Batch Records (MBRs), Generic Master Batch Records (GMBR), Parameter Value List (PVLs), and parameterized Master Batch Records (PMBRs).
  • Testing, ensuring the functionality of MBR as per the manufacturing compliance, and qualifying the Master Batch Records and recipes.
  • Diagnosed and resolved WERUM PAS.|X issues in EBPR execution and SAP interface.
  • Conducted mock executions in PAS|X Quality System and porting of MBR, ESP, PMBR, GMBR, and PVL to the production system.
  • Managed multiple functional designs in parallel, ensuring timely delivery.
  • Analyzed user behavior and feedback to optimize design and user experience.
  • Streamlined design processes, resulting in increased efficiency and faster project completion times.
  • Managed design library, ensuring resources were up-to-date and easily accessible to team.

Production Sr. Executive

Biocon Biosphere Limited
01.2022 - 08.2023
  • Managed the production of multiple bio pharmaceutical products across upstream and downstream operations.
  • Performed Cleaning in Place (CIP), Pressure Hold Test (PHT), and Sterilization in Place (SIP).
  • Managed change controls, deviations, and incidents.
  • Trained teams on SOPs and implementation on the shop floor.
  • Completed SAP transactions on time for reservations, notifications, and postings.
  • Designed digital logbooks in PAS.|X aligned with equipment functions and standard operating formats.
  • Integrated L-2 with PAS. |X (3.1.8) using MSI integration in PAS.|X MBR Designer.

Production Sr. Executive

JC Biotech Private Limited
11.2011 - 12.2021
  • Specialized in fermentation and production management.
  • Managed various products and executed multifaceted manufacturing processes.
  • Performed thorough cleaning and testing procedures on large-scale fermentation equipment.
  • Preparation, training, and implementation of SOPs for shop floor activities.
  • Managed day-to-day activities on the shop floor, coordinating with all the teams.
  • Closure of process orders in SAP, post-completion of the batch.
  • Creation of the monthly production report and finalizing the available stocks on the shop floor.

Education

Bachelor of Technology - Biotechnology

Vignan's Engineering College
Vadlamudi
05.2010

Skills

STRENGTHS

  • Biopharmaceutical Production Specialist
  • Expert in biopharmaceutical production and MES PAS|X digital systems integration, improving efficiency of manufacturing process
  • MES Implementation Expert
  • Proficient in administering PAS X systems, including configuration of Administration Functions (AFs) and Equipment Functions (EFs), and designing and executing MBR trials using Werum PASX (versions 3.1.8, 3.3.4, 3.3.5) with integration through historian and XML-based interfaces.

KEY ACHIEVEMENTS

  • MES Implementation Leadership
  • Successfully led the MES implementation for PAS|X, ensuring compliance with industry standards and significantly enhancing operational efficiency

Certification

Certified MBR designer from Koerber.

Timeline

Certified MBR designer from Koerber.

09-2025

Certified MES PAS-X Administrator.

09-2025

Certified GMBR designer from Koerber.

09-2025

PAS|X Application Owner & Administrator

TheraNym Biologics Private Limited
02.2025 - Current

PAS|X MBR Designer

Dr. Reddy's Laboratories
08.2023 - 01.2025

Production Sr. Executive

Biocon Biosphere Limited
01.2022 - 08.2023

Production Sr. Executive

JC Biotech Private Limited
11.2011 - 12.2021

Bachelor of Technology - Biotechnology

Vignan's Engineering College

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Venkatesh DoddapaneniMES PAS-X Application Owner and MBR Designer