Validation Test Engineer

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job title: Sr Validation Test Engineer

Location: Summit, NJ

Duration: 12+ Months

Job Description:

Participates in the planning, conduct, and evaluation of software testing for a complex enterprise-level business solution.

Analyzes Software Requirements

Prepare Test/Validation plan, Requirement traceability report and Test/Validation summary report

Develop manual, automation test scripts and contribute for peer reviews

Executes Validation Scripts

Follows all applicable work practices, standard operating procedures and guidelines

Understanding of the purpose of validation.

Understanding of the overall validation approach for a project.

Understanding of IT processes and the lifecycle of IT systems.

Familiarity with FDA regulations (such as 21 CFR 11), GxP, SOX, EudraLex (such as Annex 11), PIC/S, including electronic records and electronic signatures.

Familiarity with testing and defect management tools such as HP ALM.

Experience in Validation functions in regulated or controlled environments