Name: Vinod Guda

Email: vinodreddy.guda8@gmail.com
Phone: 669-238-6256

Professional Summary:
 Over 8 years of experience in Life Sciences Industry as Quality Reviewer, Validation Lead, Test Lead and
Technical Reviewer/Writer.
 Experience with Emerson DeltaV with a full understanding of structure and navigation.
 Experience with Automation Infrastructure and Data Integrity.
 Familiar with the validation of computerized systems used within biopharmaceutical manufacturing and QC
labs.
 Demonstrated experience in Quality reviews, Computer System Validation Testing Strategies and Business
Analysis.
 Expertise in validation management expertise in Systems Development Life Cycle (SDLC) and GAMP
categories.
 Exposure to SAP, Quality Center ALM, DeltaV, PLCs, Siemens Building Automation System.
 Experience in Strategic planning, Systems Analysis, Risk Management and Scope Control.
 Understands the requirements of a Biopharma/regulated environment.
 Specialist in documenting/reviewing/approving all the following validation deliverables – Regulatory
Assessments, Vendor Assessments, Validation Plans, 21 CFR Part 11 Assessments, Peer Review/Compliance
Assessments, Remediation Plans, Qualification Plans, URS/FRS, Trace Matrices, IQ/OQ/PQ Test protocols and
scripts, Qualification Reports, Deviation/Incident Reports, Problem Reports, Change Controls, Addendums and
Validation Summary Reports.
 Read and interpret design documents to develop test protocols.
 Work with multidisciplinary team to extract the relevant information for protocols.
 Experience with process automation, control system integration, and process control.
 Experience in Scope Control, Business Continuity, Stakeholder Management.
 Experience in coordinating communications between IT Application Teams, Infrastructure & Operations, IT
Quality and Business Teams.
 Experience in monitoring, developing and executing test cases including Positive Testing, Negative Testing,
Regression Testing, Cross Functional Testing, System Integration Testing
 Specific expertise in developing Testing scenarios and validation documents in accordance with SDLC and
company SOPs.
 Good working experience in analyzing changes and identifying areas of applications to be regression tested.

Experience:
GE Healthcare, Marlborough Mar 2019 to Till
Date
Validation Engineer

 Worked within Qualification Services Automation Team to develop Verification, Commissioning, and
Qualification procedures for Flex Factory under Emerson DeltaV.
 Authored and approved the test protocols for the given requirements using the Emerson DeltaV.
 Authored and approved Test Scripts for Alarms (Configuration and Functional), Phases, Control Modules
(VM), Interlocks, Recipes, Software Functionality and Hardware Functionality.
 Assisted Technical and Functional Team in Determining the critical parameters and Define Process/Quality for
Alarm Functionality.
 Worked on 10 different equipment in writing test protocols i.e., XDR, XDUO, WAVE25 and Remote Scales.

Page: 1
  Developed User Requirements Specifications, Functional Requirements Specifications and System Design
Specifications.
 Developed Commissioning and Qualification protocols based on design documents.
 Worked with Automation Infrastructure and Data Integrity.
 Involved in enforcing testing methodologies for various manufacturing systems.
 Participated in change control reviews.
 Responsible for continuous improvement of the computerized system validation programs.
 Ensured requirements are adequately tested following a risk-based approach
 Identify and log issues found during validation execution.
 Developed/Maintained the Requirements Traceability Matrix (RTM).

Convatec, NJ Jun 2016 to Mar 2019

Validation Engineer
 Supported DeltaV and siemens BMS systems validation projects by writing and executing validation protocols
ensuring compliance with cGMPs as well as site policies and procedures.
 Implemented risk-based approach following GAMP Categories.
 Worked closely with project team to identify and prioritize issues early on and track validation incidents to
closure.
 Supported change control management as validation technical resource and ensured timely completion of
required tasks.
 Reviewed and approved validation impact analysis and risk assessments.
 Develop project schedule and coordinate activities across all departments.
 Reviewed and approved Master Test Plans to strategize the validation approach as well as test approach in
various test cycles.
 Reviewed and approved IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Trace Matrix, and
Validation reports.
 Authored DeltaV qualification protocols and support documents (amendments, repeat test forms, addenda and
deviations).
 Provided validation expertise, interpretation and direction in regard to computer systems validation, federal
regulations and other quality requirements.
 Worked with System Owners to ensure requirements/specifications are defined in a clear, testable format.
 Interfaced with Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely
protocol execution and remediate issues during protocol execution.
 Scheduled and coordinated DeltaV and BMS validation activities with system owners and key stakeholders.

Cardinal, OH Apr 2014 to Jun 2016

Validation Analyst
 Involved in validating DeltaV, SCADA and Siemens BMS systems.
 Implemented the automated systems in order to replace the traditional paper-based process.
 Involved in defining the Change Control Management processes.
 Reviewed and approved Validation Master Plans and Testing Strategies.
 Reviewed and approved User Requirements Specifications, Functional Requirements Specifications and System
Design Specifications.
 Developed validation scripts based on System Design configurations.
 Developed Operation qualification scripts based on functional requirements specifications.
Page: 2
  Develop Performance qualification scripts based on user requirements specifications.
 Responsible for tracking, scheduling, managing, and documenting validation activities on daily basis.
 Maintained automation systems, equipment and software applications inventory.
 Involved in processing, reviewing change control documents and perform periodic assessment on Standard
Operating procedures and GMP related forms.
 Trained automation team on change control processes.
 Involved in developing detail Test Plans for different benefit packages according to Business requirements
documentation.
 Worked with many third-party implementers in documenting test scripts, that interfacing with central
repository.
 Developed DeltaV and BMS automation scripts.
 Maintained Test Matrix which gives overview of the Testing Effort
 Acting as liaison between end user and Facets for user problems, outstanding issues, training needs and new
software releases
 Automated processes for repeated regression testing and analysis

Church and Dwight Ewing, NJ May 2012 to Mar

2014
Validation Analyst

Responsibilities:
 Involved in each phase of validation of Wonderware and SCADA – authoring, executing and documenting IQ,
OQ and PQ as part of remediation effort.
 Extensive experience in Test method validation with thorough understanding of quality systems and procedures,
cGMP, analytical testing, method development, validation & transfer, cleaning validation & verification,
process development, scale up/optimization, process validation.
 Prepared and executed validation protocols (IQ, OQ and PQ) on packaging equipment, preparing and executing
protocols FATs and SATs as part of remediation effort.
 Analyzed validation test data to determine whether autoclave systems or processes have met validation criteria
and identified root causes of production problems.
 Reviewed and approved validation and performance qualification protocols for new or modified manufacturing
processes, systems, or equipment for pharmaceuticals and other types of production.
 Created, populated or maintained databases for tracking validation activities, test results, or validated systems.
 Validated custom configured Process Compliance software package used for web-based generation, storage,
retrieval and reporting of NCMR (non-conforming materials reporting), ER (exception reporting) and CAPA
(corrective and preventative action) processes.
 Interface with outside regulatory and compliance personnel (including FDA) during plant audits and related
activities.
 Interact with multiple functions across sites including Assay Development, Engineering, Manufacturing,
Technical Operations, Regulatory, Quality Compliance, and OEMs.
 Directed remediation activities such as protocol creation or testing and ensuring compliance with cGMP.
 Documented evidence was obtained to demonstrate that the objectives of the study were satisfied.
 Involved in root cause analysis for discrepancies observed during the execution of IOQ and PQ.
 Active participation in closing out the gaps by performing the CAPA analysis during the validation activities

Page: 3
  Reviewed Standard Operating Procedures (SOPs) for various functionalities.
 Involved in Process Failure Mode Effects Analysis (PFMEA) completion.
 Responsible for ensuring the compliance of GMP/GLP and FDA regulations.

Abbott, IL Apr 2011 to Apr

2012
Test Analyst
 Created and implementing Test plans and Test Cases as per the business requirements using Quality Center.
 Implemented the whole life cycle of QA Methodology starting from Planning, Capturing, Creating, Executing,
Reporting and Tracking the defects through Quality Center
 Involved in Backend testing using SQL Queries
 Documented Test Cases for Regression, functional and smoke testing.
 Involved in Black box testing to know the basic functionality of application
 Synchronized Tests to handle the anticipated timing problems by using Load Runner.
 Worked with Reusable Actions that can be called multiple times by the test in which it was created as well as by
other tests using Quality Center
 Parameterized Steps, Checkpoints and Variables in the script to run the test on multiple sets of data.
 Wrote test plans and test scripts according to the requirement.
 Ran automated scripts for regression testing.
 Conducted Security testing, Functionality, Interface, User Accepting Testing Integration testing and Gray Box
testing during the various phases of the project
 Implemented the whole life cycle of QA Methodology starting from Planning, Capturing, Creating, Executing,
Reporting and Tracking the defects

Educational: Masters in Electrical Engineering, North Western Polytechnique university, CA

Page: 4