CSV ENGINEER II

About Capricor Therapeutics

Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX™ platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future.

About the Role

We are looking for a CSV Engineer II to join our R&D group. In this role, you will ensure 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:

• 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.

Requirements:

• Bachelor’s degree in Computer Science, Engineering, or a related field.
• Proven 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.
• Relevant certifications (e.g., Certified Validation Professional) preferred.

Preferred Skills:

• Experience with flow cytometry, functional assays, and DNA, RNA, and protein analysis might be beneficial in a broader R&D context at Capricor.

Compensation (USD): $90,000 - $105,000

This role offers a competitive salary based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development.

Location Policy:

This position is based at our headquarters in San Diego, California, with flexibility for occasional remote work as needed.

Come Work With Us! 

Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that’s transforming the biotech industry, we’d love to hear from you!