Manager, Quality Engineering

Position Summary: The Manager, Quality Engineering is a hands-on role responsible for providing strategic direction, quality oversight and execution of validation activities for facilities, utilities, equipment, computerized systems, and manufacturing processes supporting cell therapy operations. This role ensures systems remain qualified/validated, and in a state of control throughout their lifecycle using phase appropriate GMPs.

Key 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.

Required Qualifications: Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline. 5 years of progressive Quality Engineering, Validation, Engineering, or Quality experience within biotechnology, pharmaceutical, or regulated manufacturing, including leadership experience. Strong knowledge of cGMP requirements, phase appropriate GMPs for validation, Quality Risk Management, qualification, validation, and lifecycle management principles. Demonstrated 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. Strong leadership, communication, decision-making, and cross-functional collaboration skills. Demonstrated ability to lead complex initiatives and influence stakeholders across technical and Quality functions.

Preferred Qualifications: Advanced degree in Engineering, Life Sciences, or related discipline. Experience in cell and gene therapy, biologics, or aseptic manufacturing. Experience supporting facility start-up, expansion, technology transfer, multi sites, and commercialization. Experience within a CDMO or multi-client manufacturing environment. Knowledge of U.S., EU, and global regulatory expectations for qualification and validation. Work Environment Work is performed in a combination of manufacturing, laboratory, warehouse, mechanical, and office environments. May work around manufacturing equipment, mechanical systems, chemicals, and hazardous materials. Required to wear appropriate personal protective equipment (PPE) and follow applicable safety and GMP requirements. May require occasional work outside of normal business hours to support maintenance needs or facility emergencies. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

Equal Employment Opportunity Statement: Made Scientific is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We make employment decisions based on qualifications, merit, business needs, and job requirements without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship status, or any other status protected by applicable federal, state, or local law. Made Scientific is committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, unless doing so would create an undue hardship.