Lab System Validation
Location
United States, United States
Job Type
Full-time
Category
other-general
Posted
June 13, 2026
Our client, a IT Services and Consulting company, is looking for a Lab System Validation for their West Point, PA location. Requirements:
+ Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
+ Experience of CSV Validation in any one of the Lab systems is must.
+ Should worked in pharmaceutical domain and its related knowledge is must
+ Good communication and technical writing skills are a must
+ Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
+ Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
+ CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Ada...
+ Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
+ Experience of CSV Validation in any one of the Lab systems is must.
+ Should worked in pharmaceutical domain and its related knowledge is must
+ Good communication and technical writing skills are a must
+ Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
+ Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
+ CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Ada...