Site Validation Specialist Role Summary
Manage a team of engineers on high-profile client sites throughout the project lifecycle. Oversee master plans and procedures to ensure compliance with Good Manufacturing Practice (GMP).
Key Responsibilities:
* Design review process and GMP risk assessment experience
* Identify commissioning and qualification strategy and define required activities
* Review technical documentation for alignment with GMP and site requirements
* Investigate and resolve technical issues with engineers and suppliers
* Schedule preparation and progress review
* Organize and review daily activities of other engineers assigned to the project
* Project management principles to coordinate site activities and reporting
Requirements:
* Degree or equivalent in an engineering-related discipline
* 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities
* Strong leadership and teamwork ability, liaising directly with clients and other key functions