Quality Engineering Manager - Cell Therapy Validation

Made Scientific, Inc.; Princeton (NJ); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Made Scientific in Princeton, NJ, seeks a Manager of Quality Engineering to lead strategic validation activities for facilities, utilities, equipment, and computerized systems used in cell therapy operations. The role ensures lifecycle management and state of control across validated systems as part of a GMP‑driven organization.

The candidate will drive quality oversight, CAPAs, deviations, change controls, and risk assessments while collaborating with Engineering, Manufacturing, Validation, and

Competenze

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• 5+ years of progressive Quality Engineering/Validation/Quality experience within biotech/pharma or regulated manufacturing, including leadership.
• Strong knowledge of cGMP, GMP validation, Quality Risk Management, qualification, validation, and lifecycle management.
• Experience with facilities, utilities, equipment, process, and computerized system validation.
• Experience with deviations, CAPAs, change control, root cause analysis, and risk assessment.
• Experience supporting regulatory inspections and client audits.

Mansioni

• Provide validation support for GMP facilities, utilities, equipment, computerized systems, and manufacturing processes.
• Establish risk-based Quality Engineering strategies, standards, procedures, and governance aligned with cGMP and regulatory requirements.
• Provide Quality oversight and approval of qualification and validation documentation and change controls.
• Partner with Engineering, Manufacturing, Validation, Quality and other functions to assess and mitigate risks.
• Provide strategic validation input for facility expansions, equipment implementation, technology transfers, and process changes.
• Investigate significant deviations with root cause analysis and CAPAs.
• Establish lifecycle management strategies to keep systems validated and in control.
• Identify trends, compliance gaps, and improvement opportunities through Quality Engineering metrics.
• Provide Quality Engineering leadership during regulatory inspections and client audits.

Conoscenze

Quality engineering leadership

Regulatory compliance

Quality risk management

Cross-functional collaboration

GMP validation

Formazione

Bachelor’s degree in Engineering or Life Sciences

Descrizione del lavoro

Made Scientific in Princeton, NJ, seeks a Manager of Quality Engineering to lead strategic validation activities for facilities, utilities, equipment, and computerized systems used in cell therapy operations. The role ensures lifecycle management and state of control across validated systems as part of a GMP‑driven organization.

The candidate will drive quality oversight, CAPAs, deviations, change controls, and risk assessments while collaborating with Engineering, Manufacturing, Validation, and