Boehringer Ingelheim Pharmaceuticals, Inc

Manager, Validation

Boehringer Ingelheim Pharmaceuticals, Inc • $100K — $130K *
Saint Joseph, MI 49085In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific or bioengineering discipline, or 15 years GMP validation experience without a degree
  • Minimum 10 years of GMP validation experience in a regulated manufacturing environment
  • At least 3 years of leadership experience in managing people or projects
  • Strong knowledge of statistics, databases, and quality principles
  • Ability to analyze validation and production data for compliance assessment
  • Exceptional planning, scheduling, and organizational skills
  • Self-motivated individual of high integrity

Responsibilities

  • Manage personnel, budgets, and projects related to systems, process, and equipment validation
  • Maintain an electronic database for tracking GXP compliance and qualification status
  • Identify regulatory compliance trends and implement updates to the validation master plan
  • Support Product and Engineering Departments in equipment selection and upgrades
  • Ensure validation procedures align with current regulatory and corporate requirements

Benefits

  • Opportunity for international collaboration and visibility
  • Support for a healthy working environment and work-life balance
  • Programs promoting employee mobility and networking
  • Competitive compensation and benefits reflecting the company's regard for employees
Full 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.

Duties & Responsibilities

  • 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

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


Desired Skills, Experience and Abilities

About Boehringer Ingelheim Pharmaceuticals, Inc

Boehringer Ingelheim Pharmaceuticals, Inc. is a research-driven pharmaceutical company that discovers, develops, and manufactures prescription medicines. The company's mission is to improve the health and quality of life of patients by developing innovative therapies. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of Boehringer Ingelheim Corporation, which is headquartered in Ingelheim, Germany. The company's research and development efforts focus on respiratory diseases, immunology, oncology, and diseases of the central nervous system. Boehringer Ingelheim Pharmaceuticals, Inc. was founded in 1885 and is based in Ridgefield, Connecticut.
Learn more about Boehringer Ingelheim Pharmaceuticals, Inc
Size
5,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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