Senior Validation Engineer, OQ PQ and Compliance Documentation

Oakland, CA - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

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

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 ma...