P2
SOFTWA.GXPREGUL8468.P2
GxP / Regulated Software & Systems Engineering — P2

JobFrame · SOFTWA.GXPREGUL8468.P2

Software Engineering · GxP / Regulated Software & Systems Engineering

P2 · P2 — Developing Professional

Median pay · United States

$72,357

$56,843$92,106 · USD · annual · national base (function pricing in review)

Median pay

$72,357

$56,843–$92,106

Level

P2

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 — P2 P2 — Developing Professional

Early-career professional; developing skills, handles routine tasks with some independence

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