Quality Engineering Manager - Cell Therapy Validation Lead

Made Scientific; Princeton (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Made Scientific, a Princeton-based cell therapy CDMO, seeks a Manager of Quality Engineering to lead validation activities for facilities, utilities, equipment, and computerized systems. This role ensures systems stay qualified and in control throughout their lifecycle, in alignment with phase-appropriate GMPs.

You will partner with Engineering, Manufacturing, Validation and Quality teams to implement risk-based strategies, oversee protocols and CAPAs, and support regulatory inspections and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• 5 years of progressive Quality Engineering, Validation, Engineering, or Quality experience in biotech or regulated manufacturing.
• Strong knowledge of cGMP requirements, phase appropriate GMPs for validation, Quality Risk Management, qualification, validation, and lifecycle management.
• Experience with deviations, CAPAs, change control, root cause analysis, and risk assessment.
• Experience supporting regulatory inspections and client audits.

Responsibilities

• Provide validation support for GMP facilities, utilities, equipment, computerized systems, and manufacturing processes.
• Establish and maintain risk-based Quality Engineering strategies, standards, procedures, and governance aligned with cGMP and regulatory requirements.
• Provide Quality oversight and approval of qualification and validation protocols, reports, change controls, deviations, CAPAs, and associated technical documentation.
• Partner with Engineering, Manufacturing, Validation, Quality, and other functions to assess and mitigate quality and compliance risks.
• Provide strategic validation input for facility expansions, equipment implementation, technology transfers, process changes, and other strategic projects.
• Ensure significant equipment, facility, and process-related deviations are appropriately investigated, with effective root cause analysis and sustainable CAPAs.
• Establish lifecycle management strategies to ensure qualified/validated systems remain in a state of control.
• Identify trends, compliance gaps, and improvement opportunities through Quality Engineering metrics and risk assessments.
• Provide Quality Engineering leadership during regulatory inspections, client audits, qualification activities, and inspection readiness efforts.

Skills

Leadership

Communication

Cross-functional collaboration

Decision making

Problem solving

Risk assessment

Education

Bachelor’s degree in Engineering, Life Sciences, or related technical discipline

Advanced degree in Engineering, Life Sciences, or related discipline

Job description

Made Scientific, a Princeton-based cell therapy CDMO, seeks a Manager of Quality Engineering to lead validation activities for facilities, utilities, equipment, and computerized systems. This role ensures systems stay qualified and in control throughout their lifecycle, in alignment with phase-appropriate GMPs.

You will partner with Engineering, Manufacturing, Validation and Quality teams to implement risk-based strategies, oversee protocols and CAPAs, and support regulatory inspections and