Technical Validation Lead

Job Summary:

The candidate responsibilities include mainly writing, executing test cases based on functional specifications and managing the validation/test phase to ensure the system release functions as expected by Baxter. The candidate should:

• 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 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
• Revise test cases as necessary based on project team feedback.
•  Work closely with the 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
•  Manage the entire testing phase: validation analysts, assignments, progress, etc.
•  Develop and execute system test cases, scripts and plans.
• Understand and follow appropriate SDLC, quality validation processes and application processes.
•  Familiar and capable of trace matrix generation
•  Support IT technical and IT validation teams for the development of the functional specifications and the functional testing 

Responsibilities:

•  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 HPALM and understand the SDLC processes.
• Experience with LIMS (LabVanatge) 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.

Qualifications:

• Experience level: Experienced
• Education: Bachelors

Skills:

• Computerized System testing
• validation
• HPALM
• SDLC processes
• GxP regulations
• project organizational skills