Validation Engineering Lead

About the role

The Lead, Quality Engineering & Support is responsible for providing strategic and operational quality leadership for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems, Warehouse, and Quality Control (QC) operations. This role ensures that all supported functions operate in compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines, Data Integrity requirements, and company quality standards. The incumbent serves as the Site Data Integrity (DI) Champion and is accountable for the quality oversight of qualification and validation activities, engineering and computerized system lifecycle management, warehouse and laboratory compliance, risk management, inspection readiness, and continuous improvement initiatives.

Key responsibilities

• Provide quality oversight for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse, and Quality Control operations

• Ensure SOPs, Quality Risk Assessment, reports, specification and quality records comply with FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity requirements, and company quality standards

• Provide independent quality decisions to ensure product quality, patient safety, data integrity, and regulatory compliance

• Review and approve deviations, investigations, CAPAs, change controls, Quality Risk Assessments (QRAs), gap assessments, SOPs, protocols, validation documentation, and technical reports

• Support and participate in audit and inspection readiness programs and represent Quality Operations during client audits and regulatory inspections

• Review and approve qualification and validation lifecycle activities, including facilities, utilities, equipment, HVAC, process gases, computerized systems, process validation, and cleaning validation

• Serve as the Site Data Integrity (DI) Champion and lead and maintain the site's Data Integrity Governance Program

• Promote and embed ALCOA+ principles across the organization

• Lead remediation activities and monitor effectiveness of corrective and preventive actions

• Drive a culture of quality, compliance, inspection readiness, operational excellence, and continuous improvement

About you

• Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, Computer Science, Information Systems, or a related discipline

• Minimum 10 years of experience in pharmaceutical, biotechnology, biologics, ADC, or CDMO environments

• Minimum 5 years of leadership experience within Quality Assurance, Validation, Engineering Quality, QC Quality, or related GMP functions

• Strong knowledge of FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Annex 11, 21 CFR Part 11, and Data Integrity requirements

• Expertise in validation lifecycle management, Quality Risk Management, compliance gap assessments, and GMP quality systems

• Strong understanding of engineering systems, utilities, HVAC, process gases, computerized systems, warehouse operations, and QC laboratory processes

• Excellent quality decision-making, stakeholder management, problem-solving, and communication skills

• Ability to balance business objectives while maintaining the highest standards of quality and regulatory compliance