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Quality Engineering Associate III - CQV

Quality Engineering Associate III - CQV

Capricor TherapeuticsSan Diego, CA, US
10 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

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.

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.

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

    • Work Environment and Physical Demands

  • Professional GMP facility environment.
  • Ability to sit or stand for extended periods.
  • Occasional lifting of materials up to 40 pounds.

    • 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.

    We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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    Quality Engineering • San Diego, CA, US