Hi Folks,
Please share the suitable resource for this Position.
Please share the Visa Copy and Photo ID Proof of your consultants. at
*manish.gu...@nityo.com
<manish.gu...@nityo.com>*
=================================================================

*Role : Verification & Validation Engineer*

*Work Location : Milwaukee, WI*

*Duration of assignment (in Months) : 12+ months*


*Rate: $35/hr*



*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

• Expertise 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*

1. Create and revise Design Verification and Validation (V&V) Procedures

2. Participate in Design Verification and Validation Procedure Reviews

3. Setup and configure Test Equipment

4. Perform dry runs and formal Verification and Validation (V&V) activities
as required

5. Perform dry runs for formal Usability test activities as required

6. Perform remediations of V&V results as required

7. 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)

9. 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

10. 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.

Thanks & Regards!
*Manish Gupta*
*Desk : **609-853-0818 **Ext. 2130*
*Email : manish.gu...@nityo.com <manish.gu...@nityo.com>*

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