Principal GMP Validation Lead

Boehringer Ingelheim; Athens (GA); On-site; USD 110,000 - 165,000; Full time

Job summary

Boehringer Ingelheim USA in Georgia seeks a Senior Specialist, Validation to manage high-level GMP validation activities at the BIAH site, ensuring compliance with the Validation Master Plan and regulatory requirements. You will coordinate cross-functional teams, schedule testing, and review critical documents to support complex validation projects.

The role requires strong project leadership, regulatory know-how, and a track record of delivering validated systems, equipment, and processes that

Qualifications

• Bachelor's degree in a scientific/engineering discipline is required.
• Minimum 6 years of GMP validation experience; more senior level with leadership is preferred.
• Experience with FDA/EU/USDA regulatory expectations is highly desirable.

Responsibilities

• Lead complex GMP validation projects from concept to process validation.
• Oversee validation documentation, CAPA assessment and change controls.
• Coordinate with QA, QC, engineering and maintenance for validation activities.

Skills

Project management

Leadership

Regulatory compliance

Education

Bachelor degree in a relevant discipline

GMP validation experience (6+ years)

Tools

MS Office

Job description

Boehringer Ingelheim USA in Georgia seeks a Senior Specialist, Validation to manage high-level GMP validation activities at the BIAH site, ensuring compliance with the Validation Master Plan and regulatory requirements. You will coordinate cross-functional teams, schedule testing, and review critical documents to support complex validation projects.

The role requires strong project leadership, regulatory know-how, and a track record of delivering validated systems, equipment, and processes that