Senior Validation Manager, GMP & Compliance

Boehringer PRD; Saint Joseph (LA); On-site; USD 120,000 - 190,000; Full time

Job summary

Boehringer Ingelheim in the United States seeks a senior validation leader to oversee equipment, process, systems and product validation for Pharmaceuticals and Vaccines at the Saint Joseph site. The role ensures compliance with cGMP, FDA, EU, USDA and BI standards, directing budgets and projects and maintaining the Validation Master Plan (VMP) to support current regulations.

Collaborating with Product and Engineering, the incumbent leads cross-functional teams, analyzes data and ensures

Qualifications

• Bachelor's degree in a scientific, bioengineering, or related discipline; minimum 10 years GMP validation experience in a GMP or regulated environment.
• In lieu of a degree, at least 15 years GMP validation experience in a GMP or regulated environment.

Responsibilities

• Manages personnel, budgets and projects related to systems, process, cleaning and equipment validation in GXP areas (Operations, R&D, Marketing) at the facility.
• Maintains comprehensive electronic data base for tracking compliance and qualification status of critical GXP equipment, systems and processes.
• Identifies regulatory compliance trends for validation procedures and updates the VMP to ensure ongoing compliance.
• Supports Product and Engineering in selecting, reviewing, acquiring, and upgrading production equipment to enable IQ/OQ/PQ validation.

Skills

GMP validation leadership

Regulatory compliance

Cross-functional leadership

Data analysis & statistics

Project management

Education

Bachelor degree in scientific discipline

Tools

GxP documentation systems

Job description

Boehringer Ingelheim in the United States seeks a senior validation leader to oversee equipment, process, systems and product validation for Pharmaceuticals and Vaccines at the Saint Joseph site. The role ensures compliance with cGMP, FDA, EU, USDA and BI standards, directing budgets and projects and maintaining the Validation Master Plan (VMP) to support current regulations.

Collaborating with Product and Engineering, the incumbent leads cross-functional teams, analyzes data and ensures