Job Title: CSV Validation Consultant - Pharma

Location: Plainfield,NJ (Hybrid)

Experience: 10 years

Job Description:

Experience in Computer System Validation (CSV) within the Pharmaceutical/Life Sciences industry.
Strong knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.
Experience preparing/reviewing URS, FRS, Risk Assessments, IQ/OQ/PQ, Validation Plans and Reports.
Hands-on experience with validation of GxP computerized systems and related documentation.
Knowledge of change control, deviation, CAPA, and SOPs.
Experience working with QA/Validation teams and supporting audits/inspection readiness.
Strong documentation and communication skills.

Email:

CSV Engineer

Key skills