CSV Associate: GxP Validation & Compliance

Krystal Biotech; Pittsburgh (Allegheny County); On-site; USD 80,000 - 110,000; Full time

Job summary

Krystal Biotech is seeking a highly motivated Computer System Validation (CSV) Associate to support validation and compliance activities for GxP computerized systems used in manufacturing, quality control laboratories, and other regulated areas.

The ideal candidate will have 2+ years of CSV/Quality Systems experience in a regulated environment and possess strong technical writing, organizational, and problem-solving skills.

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.
• Knowledge of IT infrastructure concepts including backups, disaster recovery, Active Directory, networking, cybersecurity, and system security is a plus.
• Familiarity with audit trail review, electronic signatures, and security/access management.
• Experience supporting cloud-based or SaaS applications in regulated environments.
• Strong technical writing, documentation, and communication skills.
• Strong organizational skills with the ability to manage multiple priorities in a fast‑paced environment.
• Ability to work independently and collaboratively within cross‑functional teams.

Responsibilities

• Support CSV activities for GxP computerized systems, analytical instruments, laboratory systems, manufacturing systems, and software applications.
• Develop, review, execute, and maintain validation documentation including URS, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Support system implementations, upgrades, configuration changes, and periodic reviews per procedures.
• Ensure systems remain validated and compliant throughout the lifecycle.
• Assist with audits, inspections, CAPAs, deviations, and change controls.
• Collaborate with QA, QC, IT, Regulatory Affairs, and vendors to support projects.
• Participate in vendor assessments and leverage documentation packages as appropriate.
• Maintain validation records in electronic document management systems (e.g., Veeva Vault).

Skills

CSV

Quality Systems

IT Compliance

GxP

FDA 21 CFR Part 11

Data Integrity ALCOA+

Veeva Vault

TrackWise

LIMS

Education

Bachelor's degree in Computer Science/Information Systems/Engineering/Life Sciences

Tools

Veeva Vault

TrackWise

LIMS

QMS

MES

Job description

Krystal Biotech is seeking a highly motivated Computer System Validation (CSV) Associate to support validation and compliance activities for GxP computerized systems used in manufacturing, quality control laboratories, and other regulated areas.

The ideal candidate will have 2+ years of CSV/Quality Systems experience in a regulated environment and possess strong technical writing, organizational, and problem-solving skills.