Krystal Biotech

Dermatology-focused topical gene therapies

Computer System Validation Associate

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timePittsburgh, PA, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related discipline is required.
At least 2 years of experience in Computer System Validation (CSV), Quality Systems, or IT compliance within a regulated environment is required.
Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles (ALCOA+), change management, and software development lifecycle methodologies is required.
Experience developing and executing validation documentation and test protocols is required.
Familiarity with laboratory and manufacturing systems such as LIMS, QMS, MES, Veeva Vault, TrackWise, analytical instruments, and standalone systems is required.
Familiarity with audit trail review, electronic signatures, and security/access management is required.
Experience supporting cloud-based or SaaS applications in regulated environments is required.
Strong technical writing, documentation, and communication skills are required.
Strong organizational skills and the ability to manage multiple priorities in a fast-paced environment are required.
The ability to work independently and collaboratively within cross-functional teams is required.

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 in accordance with 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 such as Veeva Vault.
Support data migration, disaster recovery, and system retirement activities as needed.
Perform additional duties as assigned.

Desired Qualifications

Experience supporting computerized systems in pharmaceutical, biotechnology, medical device, or other regulated industries is preferred.
Knowledge of IT infrastructure concepts, including backups, disaster recovery, Active Directory, networking, cybersecurity, and system security, is a plus.

About Krystal Bio:

At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.

Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

Job Description 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 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.

Primary 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.

Minimum Qualifications & Desired Competencies:

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.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

About the Company

Krystal Biotech

Dermatology-focused topical gene therapies

Krystal Biotech develops and sells gene therapies for rare dermatological diseases. Its lead product, VYJUVEK (beremagene geperpavec-svdt), is a topical gene therapy designed to treat dystrophic epidermolysis bullosa (DEB) by delivering a corrected gene directly to the skin so that damaged skin can heal. The company’s STAR-D platform enables off-the-shelf gene therapies that can be used across a range of skin conditions and the VYJUVEK therapy is designed to be redoable, meaning its treatment can be repeated if needed. Krystal Biotech stands out by owning exclusive worldwide rights to its therapies and by being the first FDA-approved medicine for DEB, a rare condition. The company’s goal is to grow its portfolio of dermatology gene therapies using the STAR-D platform to provide accessible, repeatable treatments for patients with rare skin diseases.

Company size: 201-500
Company stage: IPO
Headquarters: Pittsburgh, PA
Founded: 2016

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