Vishnu Ratakonda
Indianapolis,IN
Summary
a detail-oriented team player with strong skills in process improvement, project management, quality management systems (QMS), and validation in the pharmaceutical industry. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Project Engineer
Fusion LIfe Sciences Technologies LLC
Alpharetta, GA
12.2023 - Current
- Lead Technology Transfer, Participated in multidisciplinary project teams through the complete product transfer to support ongoing client projects on time.
- I worked with the R&D, Facilities and Validation team on process implementation to develop a detailed plan based on the approved scope of work
- Reviewed technology transfer documents such as product development reports, batch manufacturing, and packaging records to provide the technical analysis for the overall process
- Developed project URS, RFQs, CCMs, work orders, preventative maintenance plans, P&ID redlines, and spare parts management, among other activities directly related to project documentation.
- Participated in technical review of all external engineering design reviews
- Lead the team in defining project strategies, developing goals and ensuring project scope is defined to meet project requirements
- . Assisted in design and procurement of new process and utility equipment
- Assisted in conducting investigations to resolve deviations, including Root Cause Analysis (RCA)
- Assisted in project IQ/OQ/PQ and change control activities.
- Interacted with all functions and levels of management, ensuring effective, ongoing communications across teams and stakeholders.
Technical Project Engineer
Tri-Pac Inc
South Bend, IN
06.2023 - 11.2023
- Involved in new product development and supported the technical transfer of existing products in contract manufacturing
- Reviewed Master Batch Records (MBR), Master Packaging Records (MPR), and Process Control Data (PCD) and got sign-off from customers for commercial production
- Developed finished batch release specification sheets and finished product specification sheets for new drug products.
- Assisted in troubleshooting, equipment/facility design, and cost improvement projects utilizing project management, Six Sigma, or other skills
- Attended weekly meetings with customers and updated project status in real-time
- Implemented change controls under senior manager supervision
- Assisted in the design and procurement of new process and utility equipment and commissioning, or qualification activities, including authoring IQ / OQ / PQ protocols, test execution, and authoring summary reports.
- worked with raw material (RM) and pack material (PM) vendors, implemented Vendor qualification
- Created a Bill of Materials (BOM) for new and existing products in SAP.
- Read and interpret blueprints, technical drawings, schematics, and computer-generated reports.
- Collaborated with the project teams and across functions in problems solving,
- Assisted with day-to-day operations, working efficiently and productively with all team members in managing projects from start to finish.
Validation Engineer Intern
Vastek Inc
San Diego, CA
05.2022 - 08.2023
- Assisted validation activities, including IQ, OQ, and PQ and conducted equipment checks to maintain compliance and operational efficiency
- Assisted in the commissioning, qualification, and validation of various equipment and systems under regulatory requirements, and ensured the functionality of equipment and systems met specified requirements.
- I worked on daily tracking and monitoring QMS for any change control requests and initiated CAPA when required
- Assisted in writing IQ, OQ, PQ, Protocols and validation guidelines to commission new equipment, Master Validation Plans, Test Method Validation (Gage R&R), Process FMEAs
- problem-solving techniques to determine root causes, troubleshooting nonconforming products, raw materials, and components, and implementing corrective and preventive action (CAPA) plans
Engineer
Siris Pharmaceuticals Ltd
VIJAYAWADA, India
12.2020 - 07.2021
- Supported in the development of validation protocols outlining procedures for testing and qualifying equipment, processes, and systems according to regulatory requirements and industry standards
- ·Assisted in maintaining documentation of validation activities, including protocols, reports, and deviations
- Supported in analyzing validation data to evaluate equipment and processes' performance, identifying deviations and non-conformities, and providing input for corrective actions
- Participated in change control processes to assess the impact of changes on validation status, assisting in implementing validation activities to ensure continued compliance
- Assisted in risk assessment to identify potential hazards and risks associated with equipment, processes, and systems, providing support in implementing mitigation strategies
- Provided support in continuous improvement initiatives to enhance validation processes, streamline workflows, and improve efficiency
Education
Master of Science - Biomedical Engineering
University of South Florida
Tampa, FL05-2023
Bachelor of Technology - Electrical, Electronics And Communications Engineering
K L University
Andhra Pradesh, India05-2021
Skills
21 CFR Parts 210, 211 and ISO 13485
New Product Development
Technical Transfer
Contract Development Manufacturing (CMO)
Quality Management System (QMS)
Good Manufacturing Practice (GMP)
Master Batch record
Project Management
Design control Experience
Stability study protocols
Pharmaceutical Research and development
Microsoft Word, Microsoft Excel, and Microsoft Project
Risk assessments (FMEA & PFMEA)
Deviations Management, CAPA, & Change Control
IQ/OQ/PQ Protocols
Non-Conformance report(NCR)
Certification
Lean Six Sigma from University of South Florida
Timeline
Project Engineer
Fusion LIfe Sciences Technologies LLC
12.2023 - Current
Technical Project Engineer
Tri-Pac Inc
06.2023 - 11.2023
Validation Engineer Intern
Vastek Inc
05.2022 - 08.2023
Engineer
Siris Pharmaceuticals Ltd
12.2020 - 07.2021
Master of Science - Biomedical Engineering
University of South Florida
Bachelor of Technology - Electrical, Electronics And Communications Engineering
K L University
Lean Six Sigma from University of South Florida
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