Senior CSV Consultant

Senior CSV Consultant

Location: Bridgewater, NJ

Duration: 12+ Months

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

Job Description

We are looking for an experienced Senior CSV Consultant to support computerized system validation projects in a regulated GxP environment . The consultant will lead CSV activities, ensure systems remain validated, and support compliance with FDA/EU regulations and company procedures.

Key Responsibilities

• 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.
• Manage validation documentation in Veeva
• Guide and train project teams and GxP system owners
• Ensure systems remain in a validated state throughout their lifecycle.

Required Skills

• 5–10+ years of hands-on CSV experience
• Strong experience with Veeva systems , including Veeva Quality, 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 (CSA) concepts.
• Strong technical writing and validation documentation skills.
• Ability to manage multiple projects simultaneously. xhyhwjd

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field