CSV Engineer
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2025-12-06
Listing for:
Katalyst CRO
Full Time
position Listed on 2025-12-06
Job specializations:
-
Pharmaceutical
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Summary
We are looking for a skilled CSV Engineer with strong experience in Veeva systems to support validation, compliance, and implementation activities in a regulated life sciences environment. The ideal candidate will have hands‑on experience working on Veeva platforms and ensuring systems meet GxP and 21 CFR Part 11 compliance.
Roles & Responsibilities- Perform Computer System Validation (CSV) activities for Veeva applications.
- Develop and execute validation documents: URS, FRS, IQ, OQ, PQ, RTM, etc.
- Ensure compliance with GxP, 21 CFR Part 11, and regulatory guidelines.
- Support validation of Veeva Vault, Veeva CRM, or other Veeva applications.
- Review and approve system changes, patches, and upgrades from a validation perspective.
- Collaborate with QA, IT, and business stakeholders to maintain validated state.
- Support audits and inspections by providing validation documentation and evidence.
- Strong experience in Computer System Validation (CSV).
- Hands‑on Veeva experience (Vault / CRM / Clinical / Quality / RIM).
- Knowledge of GxP, 21 CFR Part 11, and GMP regulations.
- Experience creating and maintaining validation documentation.
- Excellent communication and stakeholder management skills.
- Experience in life sciences or pharmaceutical domain.
- Exposure to cloud‑based system validation.
- Understanding of SDLC & Agile environments.
- Entry level
- Contract
- Pharmaceutical Manufacturing
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