Capricor Therapeutics, Inc. · 1 day ago
CSV Engineer II
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$85K/yr - $95K/yr
2+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. They are seeking a meticulous and detail-oriented CSV Engineer to ensure that computerized systems comply with regulatory requirements, developing validation protocols and providing technical expertise.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Lead Data Process Flow Mapping activities to ensure all GMP systems are compliant with 21 CFR Part 11 regulations in preparation for BLA and PLI
Ensure Computer System Operation and Administration SOPs are developed for all applicable GMP systems in preparation for PLI
Lead and assist in Packaging and Label Validation activities
Develop and execute validation protocols (IQ, OQ, PQ) for computerized systems to ensure compliance with regulatory requirements (e.g., FDA, GMP)
Perform risk assessments and impact analyses related to system changes or updates
Collaborate with cross-functional teams to define user requirements and specifications for computer systems
Write and review technical documentation, including validation plans, test scripts, and summary reports
Conduct testing and document results to ensure systems meet functional and performance requirements
Provide technical support and guidance to project teams throughout the system lifecycle
Stay informed about industry trends and regulatory changes to ensure compliance
Participate in audits and inspections, responding to findings and implementing corrective actions as needed
Support continuous improvement initiatives related to CSV processes and procedures
Other responsibilities as assigned related to computer system validation
Qualification
Required
Bachelor's degree in Computer Science, Engineering, or a related field
Prove experience (2+ years) in CSV within a regulated industry (pharmaceuticals, medical devices, etc.)
In-depth knowledge of FDA regulations (21 CFR Part 11, Part 210/211) and GMP guidelines
Strong understanding of validation principles, methodologies, and best practices
Experience with validation tools and documentation systems (e.g., Document Management Systems, LIMS)
Excellent analytical and problem-solving skills, with keen attention to detail
Effective communication skills, both verbal and written, with the ability to convey technical information clearly
Ability to work both independently and collaboratively in a team environment
Preferred
Relevant certifications (e.g., Certified Validation Professional)
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
MarketScreener
2025-12-17
Genetic Engineering News
2025-12-09
Company data provided by crunchbase