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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.

Validation (CSV) Associate

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