Biotech CSV Associate: GxP Validation & Compliance

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); On-site; USD 70,000 - 95,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a motivated CSV Associate to support validation and compliance for GxP computerized systems across Manufacturing, QC labs, and other regulated areas.

You will help implement, qualify, maintain, and manage lifecycle of these systems to meet regulatory requirements. The ideal candidate has CSV experience in a regulated environment with strong technical writing, organization, and problem-solving skills.

Qualifications

• Bachelor's degree in a related field.
• 2+ years of CSV, Quality Systems, or IT compliance in a regulated environment.
• Experience with CSV in pharma/biotech/medical devices is preferred.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity (ALCOA+)
• Experience developing and executing validation docs and test protocols.
• Familiarity with laboratory and manufacturing systems (LIMS/QMS/MES/Veeva Vault/TrackWise)
• Knowledge of IT infra concepts including backups, disaster recovery, AD, networking, cybersecurity.

Responsibilities

• Support CSV activities for GxP computerized systems, analytical instruments, lab systems, and manufacturing systems.
• Develop, review, execute, and maintain validation docs (URS, IQ/OQ/PQ, SOPs, Protocols).
• Support system implementations, upgrades, configurations, and periodic reviews.
• Ensure systems remain validated and compliant throughout lifecycle.
• Collaborate with QA, QC, Manufacturing, IT, Regulatory, R&D, Supply Chain and vendors.
• Participate in discrepancy investigations, CAPAs, deviations, and change control.

Skills

Technical writing

Documentation

Communication

Organizational skills

Problem-solving

Cross-functional collaboration

Education

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

Tools

Veeva Vault

TrackWise

LIMS

QMS

MES

Job description

Krystal Biotech, Inc. is seeking a motivated CSV Associate to support validation and compliance for GxP computerized systems across Manufacturing, QC labs, and other regulated areas.

You will help implement, qualify, maintain, and manage lifecycle of these systems to meet regulatory requirements. The ideal candidate has CSV experience in a regulated environment with strong technical writing, organization, and problem-solving skills.