CSV Associate — Drive GxP Validation in Biotech

krystalbiotech; Pittsburgh (Allegheny County); On-site; USD 70,000 - 110,000; Full time

Job summary

Krystal Biotech is seeking a CSV Associate to support validation and compliance for GxP computerized systems across Manufacturing, QC labs, and other regulated areas. The role focuses on lifecycle management, validation documentation, and adherence to regulatory requirements.

The ideal candidate will have experience with CSV in a regulated setting, strong technical writing, and the ability to collaborate with QA, IT, Regulatory, and R&D teams to ensure ongoing compliance.

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related discipline.
• 2+ years of experience in Computer System Validation (CSV), Quality Systems, or IT compliance within a regulated environment.
• Experience supporting computerized systems in pharmaceutical, biotechnology, medical device, or other regulated industries preferred.
• Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity principles (ALCOA+), and Change Management and SDLC methodologies.
• Experience developing and executing validation documentation and test protocols.
• Familiarity with laboratory and manufacturing systems such as LIMS, QMS, MES, Veeva Vault, TrackWise, analytical instruments, and standalone systems.

Responsibilities

• Support CSV activities for GxP computerized systems and laboratory/manufacturing software.
• Develop, review, and maintain validation plans, URS, FDs, IQ/OQ/PQ, TRMs, and Validation Summary Reports.
• Assist with system implementations, upgrades, and change controls.
• Ensure systems stay validated and compliant throughout their lifecycle.
• Assist with audits, CAPAs, deviations, and 21 CFR Part 11/Data Integrity compliance.

Skills

CSV experience

Technical writing

Regulatory compliance

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in CS/IS/Engineering/Life Sciences

Tools

LIMS

QMS

MES

Veeva Vault

TrackWise

Job description

Krystal Biotech is seeking a CSV Associate to support validation and compliance for GxP computerized systems across Manufacturing, QC labs, and other regulated areas. The role focuses on lifecycle management, validation documentation, and adherence to regulatory requirements.

The ideal candidate will have experience with CSV in a regulated setting, strong technical writing, and the ability to collaborate with QA, IT, Regulatory, and R&D teams to ensure ongoing compliance.