Energy Jobline ZR
Quality Engineering Associate III - CQV in San Diego
Energy Jobline ZR, San Diego, California, United States, 92189
Overview
Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide. We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
Job Description
Capricor Therapeutics, a publicly traded (NASDAQ: CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologics—focusing on cell and exosome-based therapies—to make a meaningful impact on patients’ lives, particularly for severe conditions like Duchenne muscular dystrophy with our lead therapy, deramiocel (CAP-1002). Our innovative work extends to our StealthX™ exosome platform, harnessing cutting-edge science to address unmet medical needs through precision-engineered solutions. At the heart of everything we do is a deep commitment to patient-centered innovation, fueled by strong academic partnerships and a passion for advancing healthcare.
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.
Familiarity with regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8–Q10).
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.
Additional Information 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.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr
Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide. We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
Job Description
Capricor Therapeutics, a publicly traded (NASDAQ: CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologics—focusing on cell and exosome-based therapies—to make a meaningful impact on patients’ lives, particularly for severe conditions like Duchenne muscular dystrophy with our lead therapy, deramiocel (CAP-1002). Our innovative work extends to our StealthX™ exosome platform, harnessing cutting-edge science to address unmet medical needs through precision-engineered solutions. At the heart of everything we do is a deep commitment to patient-centered innovation, fueled by strong academic partnerships and a passion for advancing healthcare.
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.
Familiarity with regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8–Q10).
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.
Additional Information 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.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr