Quality Engineering Manager, Cell Therapy Validation

ADP, Inc.; Princeton (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Made Scientific, a Princeton based cell therapy CDMO, is seeking a hands-on Manager, Quality Engineering to lead validation activities for facilities, utilities, equipment, and computerized systems supporting cell therapy operations. The role ensures systems remain qualified and in control through lifecycle management, risk-based strategies, and effective CAPAs, deviations, and change control.

You will collaborate with Engineering, Manufacturing, Validation, Quality, and regulatory affairs, and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related.
• 5+ years in Quality Engineering/Validation with leadership.
• Strong knowledge of cGMP, validation, QRM, lifecycle.
• Experience validating facilities, utilities, equipment, systems.
• Experience with deviations, CAPAs, change control, RCA.
• Experience supporting regulatory inspections and audits.
• Strong leadership and cross-functional collaboration.
• Ability to lead complex initiatives and influence stakeholders.

Responsibilities

• Provide validation support for GMP facilities, utilities, equipment, and systems.
• Establish risk-based Quality Engineering strategies and governance.
• Approve qualification/validation docs, change controls, deviations, CAPAs.
• Partner with Engineering, Manufacturing, Validation, Quality to mitigate risks.
• Provide validation input for facility expansions, tech transfers, changes.
• Investigate deviations with root cause analysis and CAPAs.
• Establish lifecycle management for qualified systems.
• Identify trends and improvement opportunities via QE metrics and risk.
• Provide QE leadership during inspections/audits and readiness efforts.

Skills

Quality Engineering

Leadership

Regulatory knowledge

Risk assessment

Cross-functional

Validation

Root cause analysis

Education

B.S. in Engineering/Life Sciences

Advanced degree (preferred)

Job description

Made Scientific, a Princeton based cell therapy CDMO, is seeking a hands-on Manager, Quality Engineering to lead validation activities for facilities, utilities, equipment, and computerized systems supporting cell therapy operations. The role ensures systems remain qualified and in control through lifecycle management, risk-based strategies, and effective CAPAs, deviations, and change control.

You will collaborate with Engineering, Manufacturing, Validation, Quality, and regulatory affairs, and