GxP Validation Specialist for Pharma & Biotech

Scorpion Therapeutics

Pittsburgh (Allegheny County)

On-site

USD 70,000 - 100,000

Full time

14 days+

Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Job summary

Scorpion Therapeutics is seeking a Computer System Validation (CSV) Associate to support GxP computerized systems across manufacturing, quality control, and regulated business areas. You will develop, review, and maintain validation documentation; collaborate with QA, IT, Manufacturing, and Regulatory teams; and assist in audits and change controls to ensure data integrity and compliance.

The role emphasizes strong technical writing and communication, with oversight of validation records, vendor

Qualifications

Bachelor’s in Computer Science, Life Sciences, or related field.
2+ years in CSV, Quality Systems, or IT compliance within regulated environments.
Experience with validated systems in pharma, biotech, or medical devices.
Knowledge of compliance standards, validation protocols, and systems such as LIMS, QMS, Veeva Vault, TrackWise.
Familiarity with IT infrastructure, cybersecurity, audit trail review, electronic signatures, and cloud-based applications.
Strong technical writing, organizational, and communication skills.

Responsibilities

Develop, review, execute, and maintain validation documentation.
Support system implementation, upgrades, and lifecycle management.
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
Collaborate across QA, QC, IT, Manufacturing, and Regulatory teams.
Assist in audits, discrepancy investigations, CAPAs, change controls, and system reviews.
Support data integrity, user access, vendor assessments, and validation records management.