Senior Validation Engineer, OQ PQ and Compliance Documentation

Overview

We need a senior validation engineer who can support OQ, PQ, documentation and audit readiness. This must align with the gaps Ricky shared.

Core Responsibilities

Write OQ protocols

Execute OQ testing

Write PQ protocols

Execute PQ performance cycles

Build traceability matrices

Create validation summary reports

Write and close deviations

Support audit readiness

Maintain change control documentation

Update SOPs for validation

Support FMEA risk work

Perform regression testing in validated systems

Required Experience

Strong OQ and PQ background

FDA regulated experience

Knowledge of 21 CFR Part 11

Knowledge of ISO 13485

GxP validation experience

Experience with LIMS, TrackWise, eQMS or similar systems