Senior CSV Consultant | GxP Validation & AI Systems

The Planet Group; Bridgewater Township (NJ); Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

The Planet Group seeks an experienced Senior CSV Consultant to lead Computer System Validation in a regulated GxP environment. You will drive validation strategies, ensure ongoing validation, and support FDA/EU compliance across multiple projects.

Responsibilities include creating Validation Plans, IQ/OQ/PQ documentation, and reviewing validation deliverables while training GxP system owners. A Bachelor’s degree is required.

Qualifikationen

• 5–10+ years of hands-on CSV experience.
• Experience with Veeva systems including QMS and RIMS.
• Experience validating GAMP Category 5/custom-built systems.
• Experience with AI tools/applications in a GxP environment.
• Knowledge of FDA Computer Software Assurance concepts.
• Strong technical writing and validation documentation skills.
• Ability to manage multiple CSV projects simultaneously.

Aufgaben

• Lead and support Computer System Validation (CSV) projects.
• Develop validation strategies for various systems including AI tools/applications.
• Manage multiple CSV projects and validation deliverables.
• Create and review Validation Plans, Summary Reports, URS/FRS, IQ, OQ, and PQ documentation.
• Support and oversee validation testing and executed protocol reviews.
• Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, GMP, GCP, and Data Integrity requirements.
• Guide and train project teams and GxP system owners.
• Ensure systems remain in a validated state throughout their lifecycle.

Kenntnisse

CSV experience

Veeva systems

GAMP 5

AI tools in GxP

CSA concepts

Technical writing

Project management

Ausbildung

Bachelor’s degree in Computer Science/Engineering/Life Sciences

Jobbeschreibung

The Planet Group seeks an experienced Senior CSV Consultant to lead Computer System Validation in a regulated GxP environment. You will drive validation strategies, ensure ongoing validation, and support FDA/EU compliance across multiple projects.

Responsibilities include creating Validation Plans, IQ/OQ/PQ documentation, and reviewing validation deliverables while training GxP system owners. A Bachelor’s degree is required.