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System validation engineer skills for your resume and career
15 system validation engineer skills for your resume and career
1. Python
Python is a widely-known programming language. It is an object-oriented and all-purpose, coding language that can be used for software development as well as web development.
- Designed and developed an automated server monitoring tool in Python.
- Set Top Box - Generated and developed system test cases for automation and manual test in Python.
2. Architecture
- Worked with logic designers and architects to review and contribute to architecture specification.
- Assisted in designing Validation Solution architecture in TestShell.
3. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Authored and executed Control System Validation protocols and provided guidance on safety and regulatory needs per FDA GAMP requirements.
- Lead auditor for Internal Process Audit activities including disposition of Minor and Major Observations to meet FDA and ISO-13485 requirements.
4. Debug
Debug is a process that focuses on detecting and correcting errors or inconsistencies in software and hardware.
- Demonstrated excellent debug and troubleshooting skills.
- Collaborated with several teams across US, China and India to debug / root cause issues and drove them to resolution.
5. GMP
GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.
- Support Good Manufacturing Practice (GMP) activities for the system upgrade change request.
- Performed Gap Analysis and Risk assessment for all GMP related computer systems.
6. Linux
Linux is a Unix-like operating system. Just like Windows, Mac OS, and IOS, Linux is an operating system used by millions across the globe. Android itself is powered by the Linux operating system. Linux manages all the hardware resources that are associated with your computer. The software is famous because of the protection it grants from viruses, malware, and crashes. The Linux operating system is entirely free and is an open-source software meaning it can be altered by those equipped with the knowledge to code.
- Provide systems engineer/admin support for senior engineers in a cloud research and development Linux environment
- Conducted functional and compatibility testing on various operating systems such as Linux and Windows.
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- Create risk assessment documentation to determine if software is GxP, GAMP, and/or 21 CFR Part 11 relevant.
- Created GxP Risk Assessment, GxP Relevancy Assessment, Part 11 Assessment document & Functional Risk Assessment.
8. Debugging
- Evaluated DSI content tests and newly released D-CAT software to insure a flawless execution through debugging root cause failures.
- Participated in continuous system integration testing, (DP) Design Prototype Vehicle commissioning and debugging.
9. Gamp
- Developed all GAMP required documentation for Validation of CIP Enhancement Project incorporating an enhanced recipe to the current CIP process.
- Create User and Functional requirements for GAMP 5 barcode labeling system.
10. Test Cases
- Assign test cases with different hardware configuration for test execution based on specific platform validation requirement.
- Created test plans and analytically-designed test cases, executing for concurrency/ focused testing.
11. Computer System Validation
- Reviewed various validation protocols; including computer system validation and equipment validation protocols.
- Manage all phases, including personnel and logistics, of Computer System Validation projects.
12. Medical Devices
Medical devices refer to apparatus for use in medical procedures.
- Directed system testing and system integration of patient monitoring and fetal monitoring projects dealing with the development of medical devices.
- Develop and write validation Installation/Operation Qualifications (IQ/OQ) for equipment used in manufacturing of medical devices.
13. Validation Plan
- Performed validation planning, document authoring, review and validation deliverable tracking.
- Involved in preparation of Validation Plan to Validation Summary Report.
14. C
- Developed new test software in C and I86 assembly.
- Developed code in C and assembly to regress the memory block that interacts with IA and microengines.
15. C++
C++ is a general-purpose programming language that is used to create high-performing applications. It was invented as an extension to the C language. C++ lets the programmer have a high level of domination over memory and system resources. C++ is an object-oriented language that helps you implement real-time issues based on different data functions
- Used C++ language to program and develop network applications for communication between different offices and for everyday office documentation maintenance.
- Developed applications in C++ and MATLAB for validating the algorithmic performance of the computer vision and optical-inertial sensor fusion library.
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List of system validation engineer skills to add to your resume
The most important skills for a system validation engineer resume and required skills for a system validation engineer to have include:
- Python
- Architecture
- FDA
- Debug
- GMP
- Linux
- GxP
- Debugging
- Gamp
- Test Cases
- Computer System Validation
- Medical Devices
- Validation Plan
- C
- C++
- IQ/OQ/PQ
- Iq Oq Pq
- Verification Testing
- Field Testing
- MATLAB
- DFMEA
- SOC
- Canoe
- PCIe
- Data Analysis
- Test Results
- Java
- QA
- Power Management
- Perl
- Embedded Systems
- Test Equipment
- URS
- Management System
- HIL
- CPU
- USB
- Windows
- Lims
- IP
- Regression
- Test Procedures
- Delta
- OS
- SQL
- ISO
Updated January 8, 2025