Qualifications

• Bachelor's degree in a scientific, bioengineering, or relevant discipline required, or 15+ years GMP validation experience without a degree.
• Minimum of 10 years GMP validation experience in a regulated manufacturing environment.
• At least 3 years in a leadership role managing teams or projects.
• Strong understanding of cGMP, FDA, EU, USDA and corporate compliance requirements.
• Proficient in statistical analysis, database management, and quality principles.
• Ability to prioritize and coordinate various project activities effectively.

Responsibilities

• Manage validation activities for systems, processes, and equipment in a GXP context.
• Maintain an electronic database to track compliance and qualification status of critical equipment and processes.
• Identify trends in regulatory compliance and update the validation master plan accordingly.
• Support selection, review, acquisition, and upgrades of production equipment to enable future qualifications.
• Oversee budget and personnel related to validation projects in GXP areas.

Benefits

• Opportunity to work in a critical compliance role for pharmaceuticals and vaccines.
• Engagement in cross-functional teams, fostering a collaborative work environment.
• Development of leadership skills through managing projects and personnel.
• Exposure to regulatory compliance trends, enhancing professional expertise.