Director of Validation

Job Responsibilities:

• Establish and maintain enterprise-wide lifecycle management strategies supporting manufacturing operations and technical systems.
• Lead validation planning and execution activities associated with facility expansion, equipment implementation, process transfer, and operational readiness initiatives.
• Develop scalable frameworks for commissioning, qualification, verification, and ongoing monitoring activities.
• Ensure validation methodologies align with applicable industry expectations and internal quality standards.
• Provide oversight for risk-based approaches to qualification and validation execution.
• Collaborate with operational and engineering teams to support implementation of new manufacturing technologies and infrastructure.
• Provide strategic guidance during startup, technology transfer, and process scale-up activities.
• Ensure technical systems remain in a validated and controlled state through effective change management and lifecycle oversight.
• Support troubleshooting efforts associated with manufacturing systems, automation platforms, and critical process equipment.
• Drive alignment between validation activities and operational performance objectives.
• Partner with quality functions to maintain inspection readiness and support internal or external audit activities.
• Ensure validation documentation, technical records, and execution activities are completed in accordance with approved procedures and data integrity expectations.
• Support investigations, deviations, corrective actions, and risk assessments related to technical systems and process controls.
• Maintain awareness of evolving industry guidance and regulatory expectations impacting validation and qualification programs.
• Promote a culture of operational discipline, technical rigor, and continuous compliance.
• Oversee lifecycle activities associated with computerized systems, automation platforms, and digital manufacturing technologies.
• Support implementation and maintenance of validated systems related to manufacturing execution, monitoring, and data management.
• Collaborate with automation and IT teams to ensure appropriate governance, security, and change control practices are maintained.
• Drive modernization initiatives supporting digital transformation and operational scalability.
• Build and develop high-performing technical teams supporting qualification, validation, and lifecycle management activities.
• Provide coaching, mentoring, and technical guidance to validation professionals and cross-functional stakeholders.
• Establish organizational priorities, resource planning strategies, and execution timelines aligned with business objectives.
• Foster collaboration across technical, operational, and quality organizations to support efficient project execution.
• Champion continuous improvement initiatives focused on efficiency, standardization, and sustainable operational growth.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• Significant experience supporting validation, qualification, engineering, or technical operations within a regulated manufacturing environment.
• Demonstrated leadership experience managing technical teams and cross-functional initiatives.
• Experience supporting large-scale capital projects, facility startup activities, or manufacturing expansion initiatives.
• Strong understanding of lifecycle management principles, change management, and risk-based validation approaches.