JobMesh

CSV Engineer II / III

Capricor Therapeutics, Inc. · San Diego, California, US

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At...

Job description

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. We are seeking a meticulous and detail-oriented CSV (Computer System Validation) Engineer to join our dynamic team. The CSV Engineer will be responsible for ensuring that computerized systems used in the biopharma industry comply with regulatory requirements. This includes developing and executing validation protocols, documenting processes, acting as the business system owner, and providing technical expertise to ensure systems operate effectively and meet industry standards. Responsibilities: Requirements: - Lead Data Process Flow Mapping activities to ensure all GMP systems are compliant with 21 CFR...