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Computer Systems Validation Specialist (GxP)

Roles & Responsibilities

  • 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

Requirements:

  • 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

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
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