Validation Engineer

Interested candidates send resumes to ravi@starkassociatesllc.com

Job Title: Validation Engineer

Duration: 6+ months

Location: North Chicago, IL

Job Description:

Author and execute test protocols to support computer system validation

Follow FDA 21 CFR Part 11 regulations, GxP regulations, Client policies/ procedures, GAMP5 best practices

Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols, User Acceptance Testing, Traceability Matrix, Validation Reports

Develop test plans

Author, execute and perform quality checks on test scripts using HP Quality Center

Document bugs/defects using HP Quality Center

Work closely and communicate with project teams to analyze requirements and build test protocols

Manage and coordinate all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews

Communicate issues that could impact scope or timeline to validation team leadership

Perform training in ISOtrain

Relies on experience and judgment to plan and accomplish goals

Is detail oriented

Performs a variety of tasks

Works under general supervision; typically reports to a manager

Requires a bachelor's degree and 4-7 years of experience