AD, 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 position is critical to the compliance effort for both pharmaceuticals and vaccines and is responsible for assuring compliance of validated systems, process, equipment to 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 our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
• Responsible for managing personnel, budgets and projects relating to systems, process, cleaning and equipment validation in GXP relevant areas such as Operations, R&D, Marketing, etc at both Kansa and Missouri facilities.
• Maintain comprehensive electronic data base for tracking compliance and qualification status of all critical GXP relevant equipment, systems and processes.
• Responsible for implementing current trends in regulatory compliance for all validation procedures for equipment, systems and processes.
• Author, implement and update the validation master plan (VMP) to assure compliance with regulatory and corporate requirements
• Providing support to Product and Engineering Departments in the selection, review, acquisition, and upgrade of production equipment to assure future IQ/OQ/PQs can be performed on equipment sourced.
• Proficiency in ISPE, USDA , EU and FDA requirements for validation.
• Performs all Company business in accordance with all regulations (e.g. EEO, FDA, etc.) and Company policy and procedures.
• When violations are noted/observed they are to be immediately reported to management.
• Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH´s excellent reputation in the community.
Requirements
• Bachelor degree from an accredited institution in a scientific discipline or bioengineering plus a minimum of five (5) years´ experience in GMP validation field. Experience must be inclusive of at least three (3) years in a leadership role.
• Must have technical competence.
• Communication skills.
• Able to make decisions & deliver results.
• Analytical thinking skills.
• Budgeting skills.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to function in a leadership role and within cross-functional teams.
• Good knowledge of statistics, data bases, 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.
Pharmaceutical Manufacturing
Quality Assurance
Full-time