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.