Chicago Chicago, IL 60007
Job Title: Validation Engineer
Location: Chicago, IL - 60007
Duration: 6+ Months Contract
About our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
Essential Duties And Responsibilities:
- Experience in validating the Laboratory Equipment, Computerized System.
- Extensive validation experience in 21 CFR Part 11.
- Good understanding of GxP standards.
- Well acquainted with all the phases of Validation Life Cycle (VLC).
- Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications).
- Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions.
- Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process.
- Good communication skills.
- Remediate legacy laboratory equipment and computerized systems related to Data Integrity; mitigate system data integrity gaps when remediation is not possible.
Responsible For Developing The Following:
- Develop/Revise Quality and Regulatory Assessment.
- Develop/Revise Risk Management Report and FMEA.
- Develop/Revise User Requirements.
- Develop/Revise Validation Plan.
- Develop/Revise Qualification Plan.
- Develop/Revise IQ/OQ/PQ Test Cases.
- Develop/Revise Requirements Trace Matrix.
- Develop/Revise Qualification Report.
- Develop/Revise Validation Report.
- Develop Change Control.
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
Vincent Gandra @ firstname.lastname@example.org ; 415-200-4129