Quality Engineering Associate 2

Capricor Therapeutics • San Diego, CA

2d • Onsite

About The Position

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 Quality Engineer III to lead equipment and facilities CQV (Commissioning, Qualification, and Validation) activities and drive continuous improvement initiatives for Capricor's GMP facility in San Diego. This senior-level role ensures compliance with internal procedures and regulatory guidelines while providing technical leadership in risk management, vendor qualification, and audit readiness. You will serve as a key resource for greenfield and brownfield facility projects, guiding quality engineering strategies that support operational excellence and regulatory compliance.

Requirements

• Bachelor's degree in a scientific or engineering discipline and 3+ years of experience in a pharmaceutical or FDA-regulated environment.
• Minimum of 3 years in Quality Engineering or validation within a GMP setting (Drug Substance or Drug Product).
• Strong knowledge of CQV principles and quality systems.
• Experience leading greenfield or brownfield facility buildouts preferred.
• Familiarity with regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8-Q10).
• Proficiency in Microsoft Word, Excel, PowerPoint, and related applications.
• Excellent written and verbal communication skills.
• Ability to work independently and collaborate effectively with technical teams.

Nice To Haves

• Preferred certifications: ASQ Quality Engineering, Six Sigma Green/Black Belt.

Responsibilities

• Lead CQV activities for equipment and facilities in alignment with Capricor procedures and regulatory standards.
• Author and approve validation protocols, reports, and related documentation.
• Collaborate with Manufacturing, Facilities, Safety, and Quality teams to maintain compliance and operational efficiency.
• Drive process improvements and implement best practices across quality systems.
• Review calibration, preventive maintenance, and service reports for GMP equipment and facilities.
• Provide technical assessments and evaluations within the change control process.
• Conduct risk assessments using tools such as FMEA, Risk Matrix, and Decision Trees.
• Oversee vendor qualification and compliance audits; prepare technical and investigation reports as needed.
• Support internal and external audits, including regulatory inspections.
• Track and report key quality metrics to inform continuous improvement initiatives.
• Lead quality-related projects and mentor junior team members.
• Perform additional duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees