Harshitha Punna
Summary
Seasoned Faclities Validation Engineer with a proven track record showcasing expertise in FDA regulations and engineering systems testing. Demonstrated leadership in guiding cross-functional teams and executing comprehensive validation projects. Excelled in risk analysis and project management, ensuring compliance and enhancing quality management systems.
Overview
4
4
years of professional experience
Work History
Facilities Validation Engineer
Revere Lifesciences, Client: Lonza Biologics
Houston, TX
11.2022 - Current
- Develop validation plans, IQ/OQ/PQ protocols, test scripts, and SOPs as required to meet 21 CFR Part 11, EU Annex 11.
- Developed gap assessments and remediation plans with an understanding of applying risk management principles.
- Generate and execute the Design Specification, Risk Assessments, and Traceability Matrix.
- Support the implementation of site-wide and departmental projects and initiatives.
- Author validation/re-validation protocols, coordinate execution, perform, and summarize qualification and validation activities.
- Developed Corrective Action Preventive Action (CAPA) workflow, including Investigation, Change Management, Document Control, Complaints, Investigation Task, Action, Request, Quality and Data Integrity, Request Extension, and Closure phases.
- Collaborated with production team members to help team create and deliver high quality, cutting-edge products.
Computer System Validation Engineer
LS Solutions Inc
08.2022 - 11.2022
- Led validation activities for Supply Chain Management, Warehouse Management System, Procure to Pay, and Record to Report modules of Oracle EBS.
- Reviewed and approved computer system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities, specifically testing-related documents.
- Develop and execute Equipment Qualification and Computer Systems Validation documentation for Manufacturing, Packaging, Facilities, Utilities, and Laboratory equipment.
- Involved in the development of validation documentation, such as the Master Plan (VMP), summary reports, functional and design specifications, test protocols (IQ/OQ/PQ), and requirement traceability matrix.
- Complete 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems.
- Leveraged Data Integrity principles to ensure specifications reflect functionality that is compliant with FDA Data Integrity guidance.
- Drafted SIT and functionality test cases for verifying the integration and functionality of Salesforce configurations.
Validation Engineer
LS Solutions, Client: Hikma Pharmaceuticals
Dayton, NJ
07.2021 - 08.2022
- Validated several pieces of equipment that are used in the clean rooms, chemistry lab, micro lab, and other customized equipment.
- Worked on equipment such as Laminar flow Hoods, Scales/balances, ACD Pumps, Bio quell Isolator Chambers, Cold Rooms, Clean rooms, Incubators, Vaporized Hydrogen Peroxide machines, Micro balances, Syringe fillers, Syringe Labelers, Auto bag machines
- Involved in the development of Verification/Qualification deliverables, including the Validation Master Plan (VMP), Validation Summary Documents (VSD), Validation Summary Reports (VSR), Risk Assessment, Requirements Documents (URS, FRS), Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Requirement Traceability Matrix.
- Performed temperature mapping for cold rooms, incubators, isolator chambers, hoods, and clean room areas.
- Performed validation on hood intelligence.
- Managed computer system validation plans and projects for the multiple systems in the plant.
- Performed Regulatory Assessment and Risk Assessment for the Manufacturing processes
- Performed GAP analysis, and developed Remediation plans
- Integrated Laboratory instruments with LIMS and validated the integration activities
- Led Change Control Management activities and managed the changes to closure.
- Performed evaluations and gap assessments of system software and analytical instruments against site procedures and FDA regulations.
Validation Engineer
LS Solutions, Client: Lubrizol Life Science Health
Bethlehem, PA
04.2021 - 07.2021
- Creation and execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), under the guidance of senior engineers.
- Document validation results, prepare reports, and ensure proper record-keeping in compliance with regulatory standards (e.g., FDA, ISO).
- Perform testing of systems, equipment, and processes to ensure they meet required specifications and regulatory requirements.
- Collaborate with cross-functional teams: Work closely with quality assurance, engineering, and production teams to support the successful implementation and execution of validation activities, and assist in troubleshooting issues as they arise.
Manufacturing Process Associate
Tekwissen, Client: HONDA
Columbus, OH
09.2020 - 04.2021
- Assembly Line Process for the Honda vehicles
- Ensuring Production processes adhere to safety and quality regulations
- Notifying Quality Assurance and Troubleshooting production flaws
- Coordinate with the team at all times, maintaining clear and open line of communication
- Servicing and maintaining production equipment
- Reviewing existing processes to lead system updates, servicing production equipment, keeping supplies and inventory and complying with production process safety and quality guideline
- Monitor equipment and production to increase production and make recommendations
- Assist staff with preparation and production, including training and explaining technical concepts
Research Associate
Southern Illinois University Carbondale
Carbondale, USA
08.2020 - 09.2020
- Study of Tribology and Testing Methods for composite materials
- Design of experiments for the different types of rubbers and its impact on the brake pad stiffness at different friction coefficient, noise levels and humidity conditions
Education
Executive MBA -
University of Cumberlands
Williamsburg, KY12-2024
Master of Science - Mechanical Engineering
Southern Illinois University Carbondale
Carbondale, IL, USA05-2020
Bachelor of Technology - Mechanical Engineering
JNTU
Hyderabad, India05-2017
Skills
- Compliance Audits
- FDA guidelines and regulations
- Evaluation of engineering systems
- Leadership - Empathy and Emotional Intelligence
- Project management
- Risk management
Affiliations
- Skilled in ballroom dancing, demonstrating proficiency in various styles such as waltz, tango, and Cha-cha, with a focus on rhythm, technique, and partner coordination.
- Expertise in teaching Yoga on various styles, including Vinyasa and Hatha, and a strong focus on promoting mindfulness, flexibility, and overall well-being.
- Responsible and compassionate pet owner of two cats, demonstrating strong multitasking, time management, and nurturing skills.
Timeline
Facilities Validation Engineer
Revere Lifesciences, Client: Lonza Biologics
11.2022 - Current
Computer System Validation Engineer
LS Solutions Inc
08.2022 - 11.2022
Validation Engineer
LS Solutions, Client: Hikma Pharmaceuticals
07.2021 - 08.2022
Validation Engineer
LS Solutions, Client: Lubrizol Life Science Health
04.2021 - 07.2021
Manufacturing Process Associate
Tekwissen, Client: HONDA
09.2020 - 04.2021
Research Associate
Southern Illinois University Carbondale
08.2020 - 09.2020
Executive MBA -
University of Cumberlands
Master of Science - Mechanical Engineering
Southern Illinois University Carbondale
Bachelor of Technology - Mechanical Engineering
JNTU
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