Comp. Sys Validation Spec

TL;DR

Comp. Sys Validation Spec (CSV/QA): Ensuring compliant documentation and validation for laboratory and product software systems with an accent on risk management, software lifecycle controls, and regulated-environment quality assurance. Focus on designing IQ/OQ/PQ validation protocols, investigating nonconformities and CAPAs, and supporting audits under FDA, CLIA, and related requirements.

Location: US Remote

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women's health, and organ health.

What you will do

• Perform software risk and impact assessments for laboratory, product, and quality management systems.
• Review software change requests, maintenance updates, test plans, protocols, and reports.
• Draft IQ/OQ/PQ validation plans, protocols, and reports and maintain software validation status.
• Provide computer system validation expertise during internal and external audits, including audit trail reviews.
• Lead or participate in cross-functional investigations of nonconformities, deviations, CAPAs, and complaints.

Requirements

• Bachelor's degree or equivalent work experience.
• 3–5 years of experience in computer system validation or product software validation.
• Experience in a CLIA laboratory and/or FDA-regulated environment.
• Strong knowledge of QA methodologies, root cause analysis, test planning, system dependencies, and product integration.
• Knowledge of software design, change control, lifecycle management, and applicable regulatory requirements, including IEC 62304, 21 CFR Part 11, 21 CFR Part 820.30 and 820.70(i), and CLIA.

Nice to have

• Experience with Microsoft Great Plains, Confluence, JIRA, SuccessFactors, LIMS, or EDMS.

Culture & Benefits

• Remote work arrangement with limited travel.
• Medical, dental, vision, life, and disability benefits for eligible employees and dependents.
• Free testing for employees and immediate family members, plus fertility care benefits.
• Pregnancy and baby bonding leave, 401(k), commuter benefits, and employee referral program.
• Inclusive workplace focused on advancing genetic disease management and personalized diagnostics.