Senior CSV Consultant
Location: Bridgewater, NJ
Duration: 12+ Months
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.
Education
Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field .
Senior CSV Consultant in bridgewater at Unknown Company
This position is listed as full time and onsite.