Computer Systems Validation Specialist (GxP)

RemoteRemoteFull Time / Part Timemid

OtherQA & TestingValidation Specialist

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Quick Summary

Overview

We’re looking for a GxP Validation & QA Specialist to help execute test cases, record validation evidence, and develop customer-facing documentation for our GxP Validation Kit.

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OtherQA & TestingValidation Specialist

We’re looking for a GxP Validation & QA Specialist to help execute test cases, record validation evidence, and develop customer-facing documentation for our GxP Validation Kit.

This role will start as a contract position, with the goal of transitioning into a full-time team member as we grow our validation and compliance operations.

You’ll work closely with our QA, Product, and Engineering teams to support validation efforts across our ELN/LIMS modules and ensure documentation meets GxP and audit standards.

Execute functional and validation test cases within our ELN/LIMS platform

Record test results, screenshots, and evidence following GxP documentation requirements

Create and maintain validation deliverables such as test reports, deviation logs, and traceability matrices

Review and improve test case design and documentation templates

Support internal QA and compliance processes, contributing to continuous improvement of our Validation Master Plan (VMP) and validation package structure

Experience with GxP validation, software testing, or quality assurance in a regulated life sciences or pharma environment

Familiarity with software validation lifecycle concepts (IQ/OQ/PQ, VMP, traceability)

Excellent attention to detail and strong written communication skills

Comfort working in a remote, fast-paced SaaS environment

Familiarity with tools like Jira and Google Workspace

Experience with ELN/LIMS, QMS, or related lab informatics systems is a plus

Experience authoring or reviewing validation documentation for SaaS or cloud-based software

Knowledge of 21 CFR Part 11, Annex 11, or ISO 13485/9001

Prior experience working with validation kits or customer-facing qualification documentation

Opportunity to help shape the validation framework for a fast-growing scientific SaaS platform

Work directly with a passionate, cross-functional team of engineers and scientists

Flexible, remote-first culture