Trackwise Digital SME

Job Title: TrackWise Digital SME

Experience: 10–12+ Years
Location: Remote

Job Summary

Seeking an experienced TrackWise Digital SME to lead administration, configuration, validation, and enhancement of the TrackWise Digital platform in a GxP-regulated environment.

Key Skills

• 4–6+ years of hands-on TrackWise Digital experience
• TrackWise Administration, Configuration & Validation
• CAPA, Deviations, Change Control, Workflow Configuration
• GxP, GMP, FDA, 21 CFR Part 11 Compliance
• Validation Lifecycle (IQ/OQ/PQ/UAT)
• APIs, Web Services & System Integrations
• ERP, LIMS, MES Integrations
• SQL, Crystal Reports (preferred)
• SDLC & Agile Methodologies

Responsibilities

• Manage TrackWise Digital administration, enhancements, and releases.
• Lead implementation, validation, and compliance activities.
• Support integrations, user management, data governance, and audit readiness.
• Collaborate with business, IT, validation teams, and vendors as the TrackWise SME.

Education: Bachelor''s Degree in Computer Science, IT, or related field.