Manager, Validation

Description

This position manages all equipment, process, systems and product-related validation activities, except GXP-related computerized systems for both Pharmaceuticals and Vaccines at the site. The role is critical to the compliance effort for both pharmaceuticals and vaccines and is responsible for assuring compliance of validated systems, processes, and equipment with current cGMP, FDA, EU, USDA, and BI corporate requirements. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of products to patients and customers.

• Manages personnel, budgets and projects related to systems, process, cleaning and equipment validation in GXP-relevant areas such as Operations, R&D, and Marketing at the facility.
• Maintains a comprehensive electronic database for tracking compliance and qualification status of all critical GXP-relevant equipment, systems and processes.
• Identifies current trends in regulatory compliance for all validation procedures for equipment, systems and processes, and implements and updates the validation master plan (VMP) to assure compliance with regulatory and corporate requirements.
• Supports Product and Engineering Departments in the selection, review, acquisition, and upgrade of production equipment to assure future IQ/OQ/PQ scans are performed on sourced equipment.

• Bachelor’s degree from an accredited institution in a scientific, bioengineering, or related discipline, and a minimum of ten (10) years of GMP validation experience in a GMP or regulated manufacturing environment.
• In lieu of a degree, a minimum of fifteen (15) years of GMP validation experience in a GMP or regulated manufacturing environment.
• Experience must be inclusive of at least three (3) years in a leadership role leading people and/or projects.
• Shares technical and compliance knowledge horizontally and vertically across the site.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to function in a leadership role and within cross‑functional teams.
• Strong knowledge of statistics, databases, and quality principles.
• Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems.
• Must be self‑motivated and of high integrity.