Validation (CSV) Associate

Scorpion Therapeutics; Pittsburgh (Allegheny County); On-site; USD 70,000 - 100,000; Full time

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.

Skills

CSV

IT compliance

Regulated environments

Technical writing

Communication

Education

Bachelor's in Computer Science, Life Sciences, or related field

Tools

LIMS

QMS

Veeva Vault

TrackWise

Job description

Role

Computer System Validation (CSV) Associate supporting GxP computerized systems in manufacturing, quality control, and regulated business areas.

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.

Requirements

• 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.

Preferred

• experience supporting SaaS systems and knowledge of cybersecurity concepts.

High-Value

regulated biotech/pharma environment, validation of manufacturing and laboratory systems, GxP compliance, audit readiness.

Work setup

not specified; likely office-based with cross-functional collaboration.