Validation (CSV) Associate

Krystal Biotech•Pittsburgh, PA

About The Position

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 business areas. This role will support the implementation, qualification, maintenance, and lifecycle management of GxP systems to ensure compliance with applicable regulatory requirements and company procedures. The ideal candidate will have experience supporting CSV activities in a regulated environment and possess strong technical writing, organizational, and problem-solving skills.

Requirements

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 developing and executing validation documentation and test protocols.
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.

Nice To Haves

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.
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.

Responsibilities

Support Computer System Validation (CSV) activities for GxP computerized systems, analytical instruments, laboratory systems, manufacturing systems, and software applications.
Develop, review, execute, and maintain validation documentation including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, and Validation Summary Reports.
Support system implementations, upgrades, configuration changes, and periodic reviews in accordance with established procedures.
Ensure computerized systems remain in a validated and compliant state throughout the system lifecycle.
Support compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements.
Author, revise, and review SOPs, work instructions, forms, and policies related to CSV, IT compliance, data integrity, and computerized systems.
Collaborate with cross-functional teams including QA, QC, Manufacturing, IT, Engineering, Regulatory Affairs, R&D, Supply Chain and vendors to support project execution and compliance activities.
Participate in discrepancy investigations, CAPAs, deviations, and change control assessments related to computerized systems.
Support audit and inspection readiness activities and assist during internal and external audits.
Perform and document periodic reviews of computerized systems per established procedures.
Assist with user access reviews, backup verification activities, and system administration support as applicable.
Support vendor assessments and leverage vendor documentation packages where appropriate.
Maintain validation documentation and records within electronic document management systems (e.g., Veeva Vault).
Support data migration, disaster recovery, and system retirement activities as needed.
Perform additional duties as assigned.