Validation Team Lead
About the Role:
* This position is responsible for leading, mentoring, and developing a skilled validation team.
* The ideal candidate will allocate resources effectively and prioritize work to meet both compliance and business needs.
* The Validation Master Plan (VMP) and associated SOPs will be owned and maintained by this role.
* All validation activities, including process cleaning, equipment, and utilities, must be executed to GMP standards.
* Process validation for new and existing products, including protocols and reporting, will be overseen by this position.
* Cleaning validation will be managed to ensure strong control over cross-contamination risks.
* Coordination of validation efforts for equipment, analytical instruments, and utilities (HVAC, water systems, etc.) is required.
* Tech transfers and new product introductions from a validation standpoint will be supported.
* Documentation must always be inspection-ready and compliant.
* Audit findings will be addressed and effective corrective actions implemented.
* Opportunities for improvement in validation processes and efficiency will be continuously sought.
* Staying up-to-date with evolving regulatory expectations and implementing best practices is essential.
Requirements:
* A degree in Engineering, Pharmaceutical Science, or a related discipline is required.
* 5+ years of experience in validation within a GMP environment, including 2+ years in a leadership role, is necessary.