CSV Engineer II

Capricor Therapeutics(28 days ago)

San Diego, CAOnsiteFull TimeMedior$84,544 - $113,660 (estimated)Quality Assurance

About this role

The CSV Engineer at Capricor Therapeutics ensures that computerized systems supporting biopharma operations meet regulatory and compliance standards. The role focuses on validation of GMP systems in preparation for key regulatory milestones such as BLA and PLI. The engineer will serve as a technical expert and business system owner for critical systems. This position supports a mission-driven biotech developing advanced cell and exosome-based therapies for rare diseases.

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Required Skills

Computer System Validation
GxP Compliance
21 CFR Part 11
GMP Compliance
Data Flow Mapping
SOP Development
Packaging Validation
Label Validation
IQ OQ PQ Testing
Risk Assessment

+17 more

Qualifications

BS in Computer Science
BS in Engineering
Bachelor’s Degree in Related Field
Certified Validation Professional

About Capricor Therapeutics

capricor.com

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a San Diego–based biotechnology company developing cell- and exosome-based therapeutics for muscular and other select diseases. Its lead candidate, deramiocel (CAP‑1002), is an allogeneic cell therapy currently in Phase 3 clinical development for Duchenne muscular dystrophy. Capricor is also advancing exosome technology as a next‑generation platform, engineering exosomes to deliver nucleic acids and proteins to treat or prevent a variety of diseases. The company focuses on translating these platforms into novel therapeutic and preventive products.