Quality Engineering Associate III - CQV
Capricor Therapeutics, Inc.Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
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
Qualifications
- 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
Skills
- CQV planning and execution
- Risk assessment and management (FMEA, Risk Matrix, Decision Trees)
- Documentation management and technical reporting
- Change control processes
- Vendor qualification and audit readiness
- Regulatory compliance with GMP and ICH guidelines
- Cross-functional collaboration
Education
- Bachelor’s degree in a scientific or engineering discipline
Additional Requirements
- Professional GMP facility environment familiarity
- Ability to sit or stand for extended periods
- Occasional lifting of materials up to 40 pounds