Verification & Validation Engineer
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Verification & Validation Engineer
Ref No.: 18-00097
Location: Boston, Massachusetts
Position Type:Contract
Experience Level: 7 Years
Start Date: 01/16/2018
 Mandatory Technical Skills:       
  • Experience as a Verification and Validation Engineer for 5+ years
  • XRAY product testing experience [System Testing experience mandatory]
  • Strong knowledge of Microsoft Windows technologies
  • Strong belief in quality compliance and following rules
  • Strong working experience on setting up lab test equipment and setting up PC and Servers and deploying software onto target systems
  • Knowledge of testing medical products
  • Knowledge of FDA regulations required to test medical products
  • Expertised in quality reviews
Desirable Technical Skills:           
  • Prepared, reviewed, executed and summarized validation protocols
  • Served as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
  • Provided validation support for the review to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control
  • Experienced in Software Development Life Cycle (SDLC) Waterfall and Agile methodologies, Manual Testing, White Box and Black Box Testing, Validation and Verification testing.
  • Experienced in testing Software, Web Applications, IVR, System Components, and Database
  • Experienced in System Performance, Unit, Functional, Regression, Integration and User Acceptance Testing.
  • Participated in writing and implementing Test Plans, Test Cases and Test Scripts/Protocols and Traceability Matrix. Executed Test Scripts/Protocols and documented Test Results. Edited and re-tested Test Scripts/ Protocols and signed off (Pass/Fail)
  • Participated in Requirements gathering, Code Reviews/ Walk Trough.
  • Hands-on experienced in Automated Test Tool –Mercury Win Runner, Load Runner and Test Director.
  • Created defect tracking (manual repository), maintained and updated defect statuses and timelines.
  • Exposure in Risk Assessment and Testing Methodologies.
  • Exposure to Protocol Creation, Execution –IQ, PQ
  • Complaints Investigation for Medical Device  (CAPA)
  • Exposure in FDA Regulations  – GMP, CGMP, GAMP, GXP, QSI, 21 CFR Part 11 and CFR Part 820, ISO 14971,  Risk Assessment for Medical Device, ISO 1345,  IEC 62304 – International Standards (Europe and US)
  • and IEEE, SEI, Six Sigma and other ISO standards and regulations.
  • Mandatory Functional Skills:       
  • Create and revise Design Verification and Validation (V&V) Procedures
  • Participate in Design Verification and Validation Procedure Reviews
  • Setup and configure Test Equipment
  • Perform dry runs and formal Verification and Validation (V&V) activities as required
  • Perform dry runs for formal Usability test activities as required
  • Perform remediations of V&V results as required
  • Record and close defects found during V&V activities
  • 8.Computer Software Validation (CSV) Test/ Protocol execution for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation (PQ)
  • Performed Dry run –Data Set Up (Role based), test script/ protocol execution for CAPA and Investigations,  per  Business, Functional Requirements and User Requirements and identify deviations (TDRs) – system, design, logic/ workflow and documentations that complies with cGMP, GxP-FDA compliance regulated computerized system that supports the Johnson & Johnson Group of Consumer Companies (JJGCC), providing CD (Consent Decree) computer validation technical consulting services for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation
  • Performed execution of approved test scripts to validate Test Results conforms with Design, FRS, URS, SOPs, Traceability Matrix in compliance with cGMP and GDP requirements.
  • Prepared, reviewed, executed and summarized validation protocols
  • Served as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
  • Provided validation support for the review to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control
Desirable Functional Skills:        
  • Understanding of healthcare environment .Experience in a medical device or pharmaceutical industry testing. Quality reviewer in verification and validation.
Total Experience Required:        
  • 6-8 years