P3
SOFTWA.GXPREGUL8468.P3
GxP / Regulated Software & Systems Engineering — P3

JobFrame · SOFTWA.GXPREGUL8468.P3

Software Engineering · GxP / Regulated Software & Systems Engineering

P3 · P3 — Mid-Level Professional

Median pay · United States

$82,468

$64,786$104,977 · USD · annual · national base (function pricing in review)

Median pay

$82,468

$64,786–$104,977

Level

P3

Super-function

technology

Demand-heat

cool

15.8% growth

Summary

GxP / Regulated Software & Systems Engineering focuses on Computer System Validation (CSV) and Computer Software Assurance (CSA) for GxP-regulated computerized systems in pharma, biotech, and medical devices. Unlike general software engineering or test-automation focuses, this focus is grounded in 21 CFR Part 11/210/211/820 and EU Annex 11 compliance, GAMP 5 risk-based lifecycle methodology, validation documentation (IQ/OQ/PQ, trace matrices, summary reports), data integrity, and audit/inspection readiness across quality and lab systems (Veeva Vault QMS, MasterControl, TrackWise, Watson LIMS, Empower, SCADA, SAP) — proving regulated systems consistently perform as intended to protect patient safety.

This level — P3 P3 — Mid-Level Professional

Fully competent professional; works independently on standard projects

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