Computer Systems Validation Specialist (GxP)

Uncountable

Remote remote Until 8/23/2026 H-1B sponsor history First posted November 2, 2025 Last posted November 2, 2025

Job description

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.

What You'll Do

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

What We’re Looking For

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

Nice to Have

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

Why Join Us

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
Potential for full-time conversion with growth opportunities in QA, compliance, or validation management

Compensation (from employer):
40–60 USD per-hour-wage

About this role

Summary

Execute validation test cases, record evidence, develop documentation, ensure compliance in SaaS platform

Job title

GxP Validation & QA Specialist

Experience level

experience in regulated life sciences or pharma environment

Industry

software

Location requirements

remote work allowed, candidates worldwide

Salary

40–60 USD per-hour-wage

Visa sponsorship

H-1B sponsor history

Management role

Skills & keywords

Required skills

GxP validationsoftware testingQAregulated life sciencesJiraGoogle Workspace

Preferred skills

validation documentationSaaS validation21 CFR Part 11ISO 13485

Specializations

GxP validationsoftware testingquality assuranceregulatory compliancevalidation documentation

Locations

Structured locations inferred from the posting.

Unknown location

Remote