Computer Systems Validation Specialist (GxP)
Uncountable
Posted: October 21, 2025
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Quick Summary
We are seeking a highly skilled Computer Systems Validation Specialist to execute test cases, record validation evidence, and develop customer-facing documentation for our GxP Validation Kit.
Required Skills
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