Previous Job
IT Validation Lead
Ref No.: 18-16671
Location: Round Lake IL, Illinois
Candidate must be local to Chicago or northern IL, southeastern WI area. If not local, then candidate should have work history in medical devices, pharmaceuticals or healthcare products (not insurance) in an FDA setting.

IT Validation Lead

Candidates need to be flexible to work in both Deerfield IL and Round Lake IL as needed.

Work with a large IT project team(s) to define Validation requirements and documentation to be used for Application/System qualification. Responsible for creating the documents required for the development and validation of the computerized system.
a. Prepares documentation within a validation package per policy and procedure to support the validation of enterprise systems and IT infrastructure.
b. Creates the Validation Plan, Qualification Plan, Qualification report(s) Final validation report, Trace Matrix, System Description, Data Migration Plan..
c. Coordinates the preparation and routes the following validation documents: Risk Management Report, User Requirements Specification, Functional Specification, Configuration Specification, Design Specification, and Data Migration Specification.
d. Completes final document processing to release validation documents within the document management system.
e. Coordinates and executes validation plans – executes the overall protocol process, including test case creation/approval, test case execution reviews, test incident management, and status reporting
f. Coaches third party testers on good testing and documentation practices.

Understands and follow appropriate Software Development Life Cycle (SDLC) quality validation processes. Excellent technical writing skills, attention to detail, Strong Communication Skills, Good Project Management Skills, proficient in MS Word, Excel and experience in Client ALM.