Senior Systems & Software Validation Engineer Resume
Objective
To Seek A Career in, Software & Systems QC/QA /Validation testing / Verification/acceptance testing procedures/Software requirements/ change control …etc…etc..
Education
Advanced software courses CBT
Advanced Software Courses
MS Computer Science
MS Computer Engg.
BS Computer Systems /Software
Skills Summary
Over Fifteen Years of Progressive Experience in Software SOFTWARE REQUIREMENTS/DESIGN REVIEWS, QC /QA Engineering./VERIFICATION, VALIDATION Testing, Documentation, Project Management, Test Plans,Design revies,performance analysis,testing,acceptance testing as follows:
Software, Cots, Systems, Integration, Applications, Programming, Debugging,Enhancements,Migrations,Verification,Testing, Project Management.
Software / Database /Integration /Programming /Client /Server /3-tier /reliability engg.
/Testing /Project Management.
System Specifications, Proposals, Requirements ,Verifications,Acceptance procedures,Performance analysis, Lifecycle Development, ,Testing and High Level Software Verification/QC/ISO 9000/9001, ISO 9001:2000, FDA standards, cGCPs, GAMP, validation principles, and change control,PVCS, 21 CFR Part 11 regulatory requirements,MIL-STD-498, and IEEE standards,, CMMI..
Computer Skills
Languages:
JAVA,HTML,XML,C, C++, VB, Visual C++,.
Software:
MS Office, Outlook and Project, QTP, LOAD RUNNER,MSAccess, Oracle ,Sql Server, Gis, Crystal Report, GUI User Interface, CAD/CAM, Idl, Omnis, Magic, Pvcs, SourceSafe.
Oper.Systems:
MSWindows, Unix, Linux, RTOS, MS-DOS, PC-DOS, CPM, VMS.
Hardware:
Pentium, Sun Work Stn, Rs-6000,As-400, Vax-11-Xxx, MicroVAX II, VAX Workstation 3200, IBM-C/AT/XT, Macintosh.
Professional Experience
Confidential,PA (2004-Present)
Senior Systems & Software Validation Engineer :
Worked as QC/QA/Test engineer /performance analysis expert for. Validation/Software Testing SOPs in support of COTS, DRAGER MEDICAL SYSTEMS, User Case Testing,V User interface/API testing,alidation testing, cGCPs, GAMP, validation principles, and change control,PVCS, 21 CFR Part 11 regulatory requirements for Pharmaceuaticals & medical imaging systems, Automated software packages for clinical hospitals,critical health care. Software Testing,Validation, Load Runner,QTP, Bounds checker,Buggs Bunny ( debugging), Test plans & Test reports,SOA for Database Testing and verification, and testing,, Client-Server interface testing, Database verification, and testing, Review protocols for completeness, cGxP compliance and data acceptability, Prepare validation summary and final test reports, Provide support to the Quality department in any regulatory inspections or audits of software systems developers or vendors
upport change control, configuration management systems, Gap Analysis and re-validation events, development of Corrective action/Preventative Action Plan for Computer Client-Server systems, for Office Automation For Very Large Customers for pharmaceuticals and medical imaging systems, validation test procedures and verification for Software, Computer systems integration, programs and code,Project Management, , Application Interface Verification And Testing,, Programming, Debugging, Performance Analysis,high level software design reviews and verifications.
Worked in MS Office, Outlook and Project, JAVA,HTML,XML C, C++,VC++,Black box/White box testing, Performance analysis. And Validation Testing for pharmaceutical industry requirements .
Confidential,Martin PA(1995 To 2004)
Senior Systems & Software Validation Engineer :
Validatin testing, Verification,QC Engg, acceptance testing for Software / Systems, Cots Software, Programming, GUI Interface, Local Area Networks, Design verification schemes,, in C, C++,Visual C++, Visual Basic, MDI, MFC, Com/D-Com, MTS, for 5 Projects on, Client/Server Environment.,Performance analysis, high level software design reviews and verifications for Systems Eng.,ISO 9000 /9001 series,2167 A procedures,programming validation , standards and coding standards verifications.
Also provided new verification methodologies for software projects,configuraton management,architecture reliability,Black box / White box testing .
Confidential,PA(1987-1995)
Senior Systems & Software Validation Engineer :
For this Manufacturer of High Resolution Workstations, For Medical Image Processing software and systems , was responsible for the following Software QC/QA/Testing Activities:
a) Software/Embedded Computer Systems, Design Verification performance Analysis, Validation testing, FDA Standars,cGCPs, GAMP, validation principles, and change control,PVCS, 21 CFR Part 11 regulatory requirements , Vendor Selection, Documentation, Reliability and Quality Control Engineering, Product Testing.
b) Verification &Validation & Performance testing of Software Systems for COTS, Computer systems, Software, Product Development and Manufacturing.
c) Verification Testing of standards for Software Programs /code in C, Visual C++.
d) Verification Testing and analysis of Software Algorithm, in C, C++.
e) Verification and reliability ?performance analysis Software Protocols for MicroVAX / Small computer Based Imaging Systems.
Confidential,Pa (1982-1987)
Systems /Software Verification Manager:
Responsible for verification,,design analysis,reviews
Value engineering,reliability engineering, Product Testing. for following software Projects :
(a) Software for Automation Test Equipment using Embedded software systems for Electronic Components,
(b) Software pkg.. for Automatic Position And Velocity Control O DC Motors Microprocessor, Automated Test Systems Using Intel 8086, 8088,8051,8096, MicroProcessors,