Overview
On Site
Full Time
Skills
URS
FRS
IQ
OQ
PQ
RTM
Regulatory Compliance
Collaboration
Quality Assurance
Auditing
Computerized System Validation
Veeva
Customer Relationship Management (CRM)
RIM
GxP
GMP
Documentation
Communication
Stakeholder Management
Life Sciences
Pharmaceutics
Cloud Computing
Software Development Methodology
Agile
Job Details
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 :
Education & Experience :
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.
Education & Experience :
- 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
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