Quality Engineering Associate III - CQV

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‚Äôs 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‚ÄìQ10)
• 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‚Äôs 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