Computer Systems Validation Consultant-- SINDC5987307
2 days ago
FL, United States
Compunnel Inc.
Full-time
$90,000 - $130,000
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Job Title: Computer Systems Validation Consultant
Location: Coral Springs, FL 33065
Duration: Long term
Interview: 2 rounds
What is the Client Looking For?
The client needs a hands-on CSV Consultant with 5+ years of SAP experience who has worked in the pharmaceutical or life sciences industry.
Key requirements:
- CSV Experience: Preparing and executing validation documents such as VP, URS, FRS, Risk Assessment, RTM, IQ/OQ/PQ, and Validation Summary Reports.
- SAP Experience: 5+ years of hands-on experience with SAP products.
- Regulatory Knowledge: Strong understanding of FDA regulations, GxP, and 21 CFR Part 11.
- Testing: Manual testing, software quality assurance, system integration testing, and validation testing.
- System Integration: Experience validating integrations involving SAP, TrackWise, Empower, and Veeva.
- Industry: Pharmaceutical, biotechnology, or life sciences experience.
Ideal Candidate Profile:
- CSV / Computer Systems Validation Consultant
- 5+ years of SAP experience
- Strong pharmaceutical / life sciences background
- Experience with GxP, FDA, and 21 CFR Part 11
- Hands-on experience with IQ/OQ/PQ and validation documentation
- Experience with SAP and laboratory/manufacturing systems
In simple terms:
The client wants someone who understands pharmaceutical compliance and computer system validation, has strong SAP experience, and can independently handle validation documentation, testing, and system integrations.
Project Overview:
- Client is looking for a Computer Systems Validation (CSV) Consultant to support its pharmaceutical R&D, laboratory, and manufacturing operations in Coral Springs, Florida.
- The project involves validating and maintaining computerized systems, software applications, and IT systems to ensure they comply with FDA regulations, GxP guidelines, and 21 CFR Part 11 requirements.
- The consultant will work on new system implementations, existing system validation, system integrations, testing, and validation documentation.