Description
CSV Engineer II / III
Team: Quality Engineering
Location: San Diego, CA
Commitment: Full-time (exempt)
Workplace Type: onsite
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:
- 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.
- 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.
- Relevant certifications (e.g., Certified Validation Professional) preferred.
Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.
Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.
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