Job description
Stefanini Group is hiring!
Stefanini is looking for
IT Validation Engineer at Remote
Location
For quick Apply, please reach out to Jaykiprasad Gupta - call:
248-728-2636 email:
Jaykiprasad.gupta@stefanini.com
Work shift (days/times) - M-F (40 hours)
Work Location - Remote
Shift: 1st shift
Description:
- The candidate responsibilities include mainly writing test cases based on functional specifications and executing test scripts to ensure the system release functions as expected by company.
Essential Responsibilities:
- Demonstrate attention to detail and accountability.
- Be responsible for assuring a system/application meets its requirements as outlined in system specification per process defined in the Validation Plan for the project.
- Identify and escalate, as necessary project risks and issues to the Validation Lead, Business Analyst, and/or Project Manager.
- Be able to prepare reports on defects and problems that arise during system testing.
- Have solid oral and written communication skills and teamwork skills.
- Be a good team player, able to meet deadlines and handle changing priorities.
- Have strong judgment capabilities to clarify requirements when necessary.
- Have the ability to work with IT management, business analysts and technical staff.
- Have solid experience working with validated systems
- Work with business representatives to ensure the test cases reflect business rules and processes
- Revise test cases as necessary based on project team feedback.
- Work closely with the Validation Lead and Business Analyst to ensure test scripts are ready for OQ and PQ.
- Other duties include: run validation test scripts as assigned, assist with preparing and updating validation documentation including specifications, defects, etc.
- As necessary modify/create Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity
Qualifications:
- Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
- Highly skilled in Computerized System testing and validation in the healthcare industry.
- The candidate must have experience with HP ALM Quality Center and understand the SDLC processes.
- Experience with TrackWise is a highly desired skill set. Additional skills required include developing operational and performance based test scripts from functional specifications.
- Knowledge of GxP regulations (e.g. 21 CFR Part 11, etc.)
- Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills.
- Excellent communication including written, verbal, and listening skills.
- Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
***Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
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