Needed Profiles ASAP!!!!!!!!!!!!!
Title: Validation Engineer Lead
Location: Northbrook IL
JOB DESCRIPTION - Computer System Validation (CSV) Lead
This position is responsible for leading and performing activities in
support of the validation and compliance of a system or application. The
Validation Lead works closely with Client stakeholders and other cross
functional teams to ensure smooth execution of the project and schedule
adherence. This position is responsible for providing subject matter
expertise and client solution in the field of Pharma/Med Devices Computer
1. Leads the Computer Validation activities within a project with high
2. Responsible for creating, managing, and/or maintaining the documents
required for the development and validation of the computerized system.
a) Create and review all validation documents in the project.
Authors Validation Plan, Training Plan, Issues Log, Design Review, IQ
Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test
Incidents, Trace Matrix, and Validation report.
Reviews Functional Specifications, Design Specifications, User Manuals,
System Procedures, System Description and Training records.
b) Creates or contributes to the Supplier Audit Report.
c) Contributes to or gathers CSV metrics for reporting purposes.
3. Oversight of protocol execution - Manages the overall protocol execution
process, including resource management, scheduling/timeline management,
incident management, and status reporting.
4. Develop internal CSV training material.
5. Lead CSV effectiveness and improvement initiatives.
6. Lead CSV knowledge development.
7. Co-ordinate between various sites for validation of Global Labeling
8. Devise Master Validation Plan in collaboration with all the responsible
project teams including documentation of the scope, detailed time
estimation, work schedule and the documentation of assumptions and risks
9. Work with respective teams to determine regulatory requirements,
validation requirements, business & functional risks and ensure
documentation of the same
10. Design templates and checklists to monitor the progress of the project
and ensure that all the required information is captured and documented
11. Responsible for URS, FRS, Risk Assessment, IQ/OQ/PQ Testing and
Validation Summary Reports.
EDUCATION and Experience
• Bachelor’s degree in Computer Science with 8-10 years of experience in
validating software systems in an FDA, GxP regulated environment.
• Experience in Life sciences or Pharmaceuticals processes / projects
especially in Product Content / Labeling is preferable.
• In depth knowledge of 21 CFR Part 11, 21 CFR Part 820 and other GxP (GMP,
GCP, GLP, GDP) regulations
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