A Software Validation Engineer is a qualified engineer who manages, calibrates, inspects, and modifies the instrument, software, and procedures used to manufacture various products. A well-drafted Software Validation Engineer Resume mentions the following duties – ensuring all systems are running correctly and efficiently to produce high-quality products; investigating the causes of equipment failures and anomalies; monitoring and testing equipment; preparing compliance reports, directing validation activities, solving testing problems, making adjustments or improvements to equipment and processes; interpreting customer requirements, developing validation schedules; and maintaining instrumentation and equipment.
Summary of skills that highlight a resume is – experience with advanced software systems design tools; strong knowledge of software architecture and solutions, skilled in writing and executing test plans, good interpersonal and communication skills, and the ability to adapt to the changing needs of technology, and technical skills. Employers seek applicants having a degree in IT or computer science.
Headline : Seeking a full-time Software Validation Engineer position in the software quality assurance field where one can use the well-rounded technical experience to deliver quality products.
Skills : Computer Programming And Processing, Word Processing, Excel, Veterinary Assistant.
Description :
Installed and configured GenBlue2 to execute the test sequences in the Test Stand (National instrument).
Executed Test Automation Scripts by using Test Stand Software (National Instrument) and also modify the test sequences according to new software builds.
Included regular software functional and system testing on Honda LTE TCU, Honda HEV (Hybrid Electric Vehicle) TCU, and Honda TRTA TCU vehicles.
Performed functional testing for Telematics Control Unit (TCU) and use OTAT (Simulator) as a Telephone Service Provider.
Re-flashed TCU board by using Teraterm in every new software builds and updated additional files in the TCU board.
Performed Regression and Integration testing on I-Call, R-Call, Remote Start, Bluetooth, Wifi, USB, Hand Free Telephone(HFT), System and Power Management, Phone, Data upload, AC Start, AC Stop.
Analyzed the SCRs (System Change Request) and execute them to validate them.
Experience
5-7 Years
Level
Executive
Education
M.Sc. In Eng
Software Validation Engineer Resume
Summary : Software Validation Engineer with 8+ years of experience. An enthusiastic and self-motivated person who believes in completing any task assigned with a positive attitude and perfection. Believe in open communication and teamwork.
Skills : Life Sciences, Agile, QA, Team Leader, QTP.
Description :
Led multiple projects independently.
Involved in various people management activities like recruitment, performance review, allotment of resources, and conflict management.
Tested using various methodologies like System Testing, Exploratory Testing, Migration Testing, Regression Testing, GUI Testing, UAT Testing, Formal Testing, Multi-User Testing, and Performance Testing.
Practiced agile-scrum process and well versed in Version One and Rally.
Involved in various Test Documentations listed below System Test Plan Document Test Completion Report Change Control Requirement Regression Checklist Migration Checklist Exploratory Checklist Release Notes Reviewing URS and FRS.
Trained, Mentored, and Nurtured new team members.
Designed and reviewed IQ & OQ scripts.
Experience
7-10 Years
Level
Management
Education
MS In Project Management
Software Validation Engineer Resume
Headline : Over 6 years of experience as a QA Analyst in the Software Testing field with multiple skills in Functional Testing, Regression Testing, Automation Testing, DataBase testing. Familiar with AGILE, Scrum, RUP, Waterfall, and Spiral Models, Business Process Testing (BPT) methodology.
Analyzed user requirement specifications and functional specifications of the embedded software.
Performed testing for Telematics Control Unit using TeraTerm, OTAT, and CANoe.
Performed manual Ad-hoc, smoke-sanity, and functional regression testing.
Prioritized and classified bugs, Generated and tracked the defects using Serena.
Created Requirement Traceability Matrix (RTM) document.
Attended daily team meetings and bug/defect scrum meetings.
Worked with the test lead, project management, and engineering teams to locate and resolve issues.
Experience
5-7 Years
Level
Executive
Education
MBA
Software Validation Engineer Resume
Headline : Seeking a Software Validation Engineer position with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.
Involved in testing the Magellan 750NAV model project.
Responsible for designing, implementing, debugging, and documenting changes.
Created an automated testing program to emulate users for GPS car navigation system with Visual Basic and HP-VEE programming language.
Created a testing procedure for the GPS systems to verify various functions of the software.
Provided a verification system to match the addresses in the database to the locations in the map software.
Performed Stress test on navigation software to verify various route calculations.
Created a Test Scenario for testing the GPS System.
Experience
5-7 Years
Level
Executive
Education
MS
Software Validation Engineer Resume
Objective : Highly qualified Software Validation Engineer with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and I would excel in the collaborative environment on which your company prides itself.
Skills : Microsoft Word, Validating Skills.
Description :
Identified scenarios; analyzed available documentation and existing software models to create test cases that identify defects, questionable functions, errors, and inconsistencies in software program functions, outputs, online screens, and content.
Identified, analyzed, and documented defects, questionable functions, errors, and inconsistencies in software program functions, outputs, online screens, and content.
Built strong working relationships with Engineering, Technical Publications, Product Management, Support, and Consultancy.
Worked closely with other parts of the organization to ensure that our testing is representative of how our customers use our products.
Contributed to the ongoing development and improvement of our Product Development Life Cycle (PDLC).
Communicated regularly with my Lead, providing accurate estimates, progress updates, raising project issues, and highlighting project concerns.
Worked closely with the rest of the department, train and support coworkers, and foster positive relationships within the team.
Experience
2-5 Years
Level
Junior
Education
Customer Service
Software Validation Engineer Resume
Objective : Quality-driven, results-focused Validation Team Leads with fifteen years of experience in the global pharmaceutical manufacturing and medical diagnostics industries. Wide-ranging expertise in Computer System Validation, Technical Writing, and Team Management. Proven ability to positively negotiate consensus and deliver solutions in challenging and fast-paced environments. Compassionate team leader with successful team-building experience and excellent technical, communication, and customer service skills.
Skills : Software Test, Planning Skills.
Description :
Hired full-time from start as a summer intern while still in college.
Originally hired as a programmer for the Validation Department but due to resource needs, was gradually moved to full-time computer systems validation responsibilities.
Experienced working with an off-shore (Italian) development team.
Programmed several Visual Basic GUIs to automate the time-consuming sample loading and result-retrieval routines required by validation engineers.
Appointed Lead Validator for a robotic sample delivery system designed for large research laboratories.
Automated centrifuge, several robotic arms for loading/unloading samples, a 100-foot pneumatic track system, and hundreds of RF-ID'd sample holding pucks.
Designed to interface with up to six of the company's analyzers which could each process up to 90 different tests.
Experience
2-5 Years
Level
Junior
Education
BS In Computer Information Systems
Software Validation Engineer Resume
Objective : Looking for a career with a company in the high-technology industry that will allow using a broad range of skills in computer software and hardware design, programming, and testing as well as in general electronics (analog, digital, and hybrid). Programming Languages: C/C++/C++.Net C#.Net, VB.Net, Python/Python.Net assembler (CPU).
Wrote test software for Platform Debug Toolkit (PDT) using C# and Python.Net.
Wrote regression test code in C# and Python.Net.
Extended PDT code coverage as necessary.
Submitted test code for review and perform code reviews for other SVE's.
Taken part in daily and weekly Scrum meetings and submit daily and weekly reports.
Tested all-wheel-drive system software using Canalyzer, Canape, and CAPL.
Prepared DVP&R to test all-wheel-drive system based on customer and internal specifications.
Experience
2-5 Years
Level
Junior
Education
BS In Software Engineering
Software Validation Engineer Resume
Objective : High-energy, strategic-thinking professional with an infectious enthusiasm for technology. More than five years of combined software, reliability, and quality validation engineering during system lifecycle (SLC), with strong analytical skills. Experience in formal testing to ensure compliance with FDA Guidance regulations (21 CFR Part 11) with respect to Medical and Pharmaceutical Devices compliance and validation issues.
Skills : Microsoft Outlook, Solidworks, Problem Solving.
Description :
Worked cross-functionally with teams to define requirements, prepare qualitative and/or quantitative tests or evaluations of processes, equipment, and systems in support of ISO 13485 and FDA requirements using current Good Manufacturing Practices (cGMP) for guidance.
Developed and maintained Standard Operating Procedures (SOP's), Work Instructions (WI), and other documents needed for software validation and verification; trained employees on required processes.
Developed test plans for software and traceability of requirements to the test cases to ensure test coverage.
Developed validation and verification methods and prepared test data.
Performed root cause analysis using problem-solving tools 8D, 5-Y's, Process map, Fishbone, C&E to identify solutions and opportunities for continuous improvement.
Implemented and executed test plans and test cases to find, document, and mitigate deviations that affect the software performance and quality in compliance with ISO 13485 and FDA Quality System Regulation (QSR) for medical.
Analyzed results, prepare supporting documents, and writes test reports adhering to ISO 13485, FDA QSR, and corporate SOP's.
Experience
2-5 Years
Level
Junior
Education
BS in Software Engineering
Software Validation Engineer Resume
Objective : Systems Engineer with 10 years of experience in product development life cycle including defining functional and design Requirements, Requirements Management and tracing, Risk analysis, DFMEA, Verification testing, and Validation for FDA regulated medical devices and life sciences. Experienced in writing System Requirements, System Specifications, Software and Hardware Requirements.
Responsible for Reverse Engineering System software Requirements.
Prepared Software requirements and Product requirements as per Standard Operating Procedure (SOP).
Worked on Documenting Validation Testing Summary Reports for existing software tests for ISO 9001 certification.
Created Traceability Matrix to ensure flow down of Project requirements.
Summarized Validation Test Reports for existing software testings into a final report.
Worked on Documenting Remediation Summary Reports.
Worked extensively on DOORS for requirement management.
Experience
0-2 Years
Level
Entry Level
Education
M.S In Biomedical Engineering
Software Validation Engineer Resume
Objective : Seeking a challenging Software Validation Engineer position in a professional environment by learning new technologies and helping the organization achieve its goals.
Skills : Project Management, V&V, Software Testing, 21 CFR Part 11, 21 CFR Part 11, ISO 13485, ISO 13485, ISO 60601, ISO 14971, Design Risk Management.
Description :
Tested Case Authoring: Created Test Case Documents testing ADMIN/LIMS environment, HR IT Quality for Lilly's learning development, Specification Method Management, External Submitter and Lot Release.
Utilized both WRQ Reflections and Rational ClearCase Explorer 2002.05.00+.
Responsible for the successful testing of 92 authored Test Cases (nearly 3600 Requirements) specific to the LIMS system.
Acted in conjunction with Management to establish procedures ensuring increased results-oriented production of final documents.
Served as a Quality Gatekeeper, analyzing Test Case format to meet Lilly standards of documentation and logic controls.
Tested functionality of Intel Setup and Configuration Software (Intel SCS).
Tested functionality of Intel SCS Add-on with Microsoft System Center Configuration Manager Work with software developers to drive issues located to resolution.
Developed, edited, and wrote test cases based on probable user usage.
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