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Validation Specialist Location: US-VA-Elkton Jobcode: 0e3e63189cd45d83e71dc161477b3b9a-122020 Email Job
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Job title: Validation Specialist
Location: Elkton VA
Sr. Validation & Compliance Engineer
Job Purpose: Support Compliance Projects and Programs
Core Job Duties:
Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information Systems
Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
Translate technical information and requirements into qualification/validation test design
Qualifications : Bachelor’s Degree; scientific background preferred
Experience : At least 3-5 years of pharmaceutical or FDA related validation experience
Good knowledge of GMPs, 21CFR Part 11, USP 1058 – and other relevant industry regulations and guidance
Work Conditions: Lab Environment (may need to follow Personal Protective Equipment and Safety Polices); Office Environment.
Validation Associates LLC
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