Senior GMP Validation & Compliance Lead

Boehringer Ingelheim; Saint Joseph (MO); On-site; USD 150,000 - 190,000; Full time

Job summary

Boehringer Ingelheim is seeking a Senior Validation Manager to oversee equipment, process and systems validation for Pharmaceuticals and Vaccines at the site. The role ensures cGMP compliance, maintains the VMP, and aligns with FDA, EU, USDA and BI requirements.

You will lead cross‑functional teams, manage budgets, and drive risk-based validation strategies to support product development, manufacturing and quality assurance.

Qualifications

• Bachelor’s degree in a scientific field with 10+ years GMP validation experience.
• In lieu of a degree, 15+ years GMP validation experience in a GMP or regulated manufacturing environment.
• Leadership experience: 3+ years leading people and/or projects.
• Strong knowledge of statistics, databases and quality principles.
• Ability to plan, schedule, organize and coordinate project activities.

Responsibilities

• 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.

Skills

Leadership

Project management

GXP knowledge

Validation expertise

Statistical analysis

Cross‑functional collaboration

Data analysis

Planning and organization

Integrity

Education

Bachelor’s degree in scientific field

Job description

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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.Duties & Responsibilities

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  Manages personnel, budgets and projects relating to systems, process, cleaning and equipment validation in GXP relevant areas such as Operations, R'D, Marketing at the facility.
  


• 
  Maintains comprehensive electronic data base 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. 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/PQscan be performed on equipment sourced.
  

Requirements

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  Bachelor degreefrom an accredited institutionin a scientific, bioengineering, or relevant discipline required, and a minimum of ten (10) years GMP validation experience in a GMP OR regulated manufacturing or similar environment.
  


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  In lieu of a degree, a minimum of fifteen (15) years GMP validation experience in a GMP OR regulated manufacturing or similar environment.
  


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  Experience must be inclusive of at least three (3) years in a leadership role leading people and/or projects.
  


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  Shares technical and compliance knowledge horizontally and vertically across the site.
  


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  Ability to plan, schedule, organize, prioritize, and coordinate project activities.
  


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  Ability to function in a leadership role and within cross-functional teams.
  


• 
  Strong knowledge of statistics, data bases, and quality principles.
  


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  Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems.
  


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  Must be self motivated and of high integrity.
  

Desired Skills, Experience and Abilities
Our Company Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com. Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com