Job Title: Lead Computer System Validation Engineer
Job Location: Durham, NC
Job Type: Contract
Pay Range: $50.00hr - $55.00hr
Job Overview:
The Lead Computer System Validation (CSV) Specialist provides hands-on validation and compliance support for computerized manufacturing systems within a regulated pharmaceutical environment. This role focuses primarily on CSV compliance, SDLC, CSA, validation governance, and quality compliance across capital and strategic projects.
Responsibilities:
Provide CSV compliance support for capital and strategic projects to ensure continuity of compliance oversight and project delivery.
Develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.
Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.
Requirements:
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