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Role: CSV Consultant
Location: Remote in US (EST, CST preferrable)
Experience: 5-10 years
A CSV Consultant is responsible for validating computerized systems used in regulated industries such as pharmaceuticals, biotechnology, healthcare, and medical devices to ensure compliance with regulatory requirements (FDA, GxP, 21 CFR Part 11).
Key Responsibilities
- Prepare and review validation documents (URS, FS, DS, IQ, OQ, PQ).
- Perform risk assessments and validation testing.
- Ensure compliance with FDA, GxP, and regulatory standards.
- Support audits, inspections, and quality assurance activities.
- Work with business, IT, and quality teams during system implementation and upgrades.
- Manage change control, deviations, and CAPA documentation.
Required Skills
- Experience in Computer System Validation (CSV).
- Knowledge of GxP, FDA 21 CFR Part 11, and validation lifecycle.
- Strong documentation and testing skills.
- Experience with pharmaceutical, biotech, or healthcare systems.
Skills:
Computer System Validation (CSV), GAMP 5, FDA 21 CFR Part 11, GxP Compliance, IQ/OQ/PQ, Validation Testing, Risk Assessment, CAPA, Change Control, Data Integrity (ALCOA+), SAP, Veeva Vault, TrackWise, LIMS, QMS, Audit Support, Documentation Management, Regulatory Compliance, Pharmaceutical & Life Sciences Systems Validation.
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